Method and apparatus for discriminating tachycardia events in a medical device

ABSTRACT

A method and medical device for detecting a cardiac event that includes sensing cardiac signals from a plurality of electrodes, the plurality of electrodes forming a first sensing vector and a second sensing vector, identifying the cardiac event as one of a shockable event and a non-shockable event in response to first processing of a first interval sensed along the first sensing vector during a predetermined sensing window and a second interval simultaneously sensed along the second sensing vector, performing second processing of the first interval and the second interval, different from the first processing, in response to the cardiac event being identified as a shockable event, and determining whether to delay identifying the cardiac event being shockable in response to the second processing of the first interval and the second interval.

RELATED APPLICATION

This application is a Continuation of U.S. patent application Ser. No.14/242,391, (now U.S Publication No. 2015/0273227), entitled “METHOD ANDAPPARATUS FOR DISCRIMINATING TACHYCARDIA EVENTS IN A MEDICAL DEVICE”,filed Apr. 1, 2014, which is incorporated herein by reference in itsentirety.

TECHNICAL FIELD

The disclosure relates generally to implantable medical devices and, inparticular, to an apparatus and method for discriminating arrhythmiasand delivering a therapy in a medical device.

BACKGROUND

Implantable medical devices are available for treating cardiactachyarrhythmias by delivering anti-tachycardia pacing therapies andelectrical shock therapies for cardioverting or defibrillating theheart. Such a device, commonly known as an implantable cardioverterdefibrillator or “ICD”, senses electrical activity from the heart,determines a patient's heart rate, and classifies the rate according toa number of heart rate zones in order to detect episodes of ventriculartachycardia or fibrillation. Typically a number of rate zones aredefined according to programmable detection interval ranges fordetecting slow ventricular tachycardia, fast ventricular tachycardia andventricular fibrillation. Intervals between sensed R-waves,corresponding to the depolarization of the ventricles, are measured.Sensed R-R intervals falling into defined detection interval ranges arecounted to provide a count of ventricular tachycardia (VT) orventricular fibrillation (VF) intervals, for example. A programmablenumber of intervals to so detect (NID) defines the number of tachycardiaintervals occurring consecutively or out of a given number of precedingevent intervals that are required to detect VT or VF.

Tachyarrhythmia detection may begin with detecting a fast ventricularrate, referred to as rate- or interval-based detection. Once VT or VF isdetected based on rate, the morphology of the sensed depolarizationsignals. e.g. wave shape, amplitude or other features, may be used indiscriminating heart rhythms to improve the sensitivity and specificityof tachyarrhythmia detection methods.

A primary goal of a tachycardia detection algorithm is to rapidlyrespond to a potentially malignant rhythm with a therapy that willterminate the arrhythmia with high certainty. Another goal, however, isto avoid excessive use of ICD battery charge, which shortens the life ofthe ICD, e.g. due to delivering unnecessary therapies or therapies at ahigher voltage than needed to terminate a detected tachyarrhythmia.Minimizing the patient's exposure to painful shock therapies is also animportant consideration. Accordingly, a need remains for ICDs thatperform tachycardia discrimination with high specificity and controltherapy delivery to successfully terminate a detected VT requiringtherapy while conserving battery charge and limiting patient exposure todelivered shock therapy by withholding therapy delivery wheneverpossible in situations where the therapy may not be required.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a conceptual diagram of a patient implanted with an exampleextravascular cardiac defibrillation system.

FIG. 2 is an exemplary schematic diagram of electronic circuitry withina hermetically sealed housing of a subcutaneous device according to anembodiment of the present invention.

FIG. 3 is a state diagram of detection of arrhythmias in a medicaldevice according to an embodiment of the present invention.

FIG. 4 is a flowchart of a method for detecting arrhythmias in asubcutaneous device according to an embodiment of the presentdisclosure.

FIG. 5 is a graphical representation of a VF shock zone according to anembodiment of the present invention.

FIGS. 6A and 6B are graphical representations of the determination ofwhether an event is within a shock zone according to an embodiment ofthe present invention.

FIG. 7 is a flowchart of a method for discriminating cardiac eventsaccording to an embodiment of the disclosure.

FIG. 8 is a flowchart of a method for determining whether the device isto transition between operating states according to an embodiment of thepresent invention.

FIG. 9 is a flowchart of a method for determining whether to transitionbetween operating states in a medical device according to an embodimentof the present invention.

FIG. 10 is a flowchart of a method for discriminating a cardiac eventaccording to an embodiment of the present disclosure.

FIG. 11 is a flowchart of a method for determining whether the device isto transition between operating states according to an embodiment of thepresent invention.

FIG. 12 is a flowchart of a method for determining whether the device isto transition between operating states according to an embodiment of thepresent invention.

FIG. 13 is flowchart of a method for determining whether the device isto transition between operating states according to an embodiment of thepresent invention.

DETAILED DESCRIPTION

FIG. 1 is a conceptual diagram of a patient 12 implanted with an exampleextravascular cardiac defibrillation system 10. In the exampleillustrated in FIG. 1 , extravascular cardiac defibrillation system 10is an implanted subcutaneous ICD system. However, the techniques of thisdisclosure may also be utilized with other extravascular implantedcardiac defibrillation systems, such as a cardiac defibrillation systemhaving a lead implanted at least partially in a substernal orsubmuscular location. Additionally, the techniques of this disclosuremay also be utilized with other implantable systems, such as implantablepacing systems, implantable neurostimulation systems, drug deliverysystems or other systems in which leads, catheters or other componentsare implanted at extravascular locations within patient 12. Thisdisclosure, however, is described in the context of an implantableextravascular cardiac defibrillation system for purposes ofillustration.

Extravascular cardiac defibrillation system 10 includes an implantablecardioverter defibrillator (ICD) 14 connected to at least oneimplantable cardiac defibrillation lead 16. ICD 14 of FIG. 1 isimplanted subcutaneously on the left side of patient 12. Defibrillationlead 16, which is connected to ICD 14, extends medially from ICD 14toward sternum 28 and xiphoid process 24 of patient 12. At a locationnear xiphoid process 24, defibrillation lead 16 bends or turns andextends subcutaneously superior, substantially parallel to sternum 28.In the example illustrated in FIG. 1 , defibrillation lead 16 isimplanted such that lead 16 is offset laterally to the left side of thebody of sternum 28 (i.e., towards the left side of patient 12).

Defibrillation lead 16 is placed along sternum 28 such that a therapyvector between defibrillation electrode 18 and a second electrode (suchas a housing or can 25 of ICD 14 or an electrode placed on a secondlead) is substantially across the ventricle of heart 26. The therapyvector may, in one example, be viewed as a line that extends from apoint on the defibrillation electrode 18 to a point on the housing orcan 25 of ICD 14. In another example, defibrillation lead 16 may beplaced along sternum 28 such that a therapy vector betweendefibrillation electrode 18 and the housing or can 25 of ICD 14 (orother electrode) is substantially across an atrium of heart 26. In thiscase, extravascular ICD system 10 may be used to provide atrialtherapies, such as therapies to treat atrial fibrillation.

The embodiment illustrated in FIG. 1 is an example configuration of anextravascular ICD system 10 and should not be considered limiting of thetechniques described herein. For example, although illustrated as beingoffset laterally from the midline of sternum 28 in the example of FIG. 1, defibrillation lead 16 may be implanted such that lead 16 is offset tothe right of sternum 28 or more centrally located over sternum 28.Additionally, defibrillation lead 16 may be implanted such that it isnot substantially parallel to sternum 28, but instead offset fromsternum 28 at an angle (e.g., angled lateral from sternum 28 at eitherthe proximal or distal end). As another example: the distal end ofdefibrillation lead 16 may be positioned near the second or third rib ofpatient 12. However, the distal end of defibrillation lead 16 may bepositioned further superior or inferior depending on the location of ICD14, location of electrodes 18, 20, and 22, or other factors.

Although ICD 14 is illustrated as being implanted near a midaxillaryline of patient 12. ICD 14 may also be implanted at other subcutaneouslocations on patient 12, such as further posterior on the torso towardthe posterior axillary line, further anterior on the torso toward theanterior axillary line, in a pectoral region, or at other locations ofpatient 12. In instances in which ICD 14 is implanted pectorally, lead16 would follow a different path, e.g., across the upper chest area andinferior along sternum 28. When the ICD 14 is implanted in the pectoralregion, the extravascular ICD system may include a second lead includinga defibrillation electrode that extends along the left side of thepatient such that the defibrillation electrode of the second lead islocated along the left side of the patient to function as an anode orcathode of the therapy vector of such an ICD system.

ICD 14 includes a housing or can 25 that forms a hermetic seal thatprotects components within ICD 14. The housing 25 of ICD 14 may beformed of a conductive material, such as titanium or other biocompatibleconductive material or a combination of conductive and non-conductivematerials. In some instances, the housing 25 of ICD 14 functions as anelectrode (referred to as a housing electrode or can electrode) that isused in combination with one of electrodes 18, 20, or 22 to deliver atherapy to heart 26 or to sense electrical activity of heart 26. ICD 14may also include a connector assembly (sometimes referred to as aconnector block or header) that includes electrical feedthroughs throughwhich electrical connections are made between conductors withindefibrillation lead 16 and electronic components included within thehousing. Housing may enclose one or more components, includingprocessors, memories, transmitters, receivers, sensors, sensingcircuitry, therapy circuitry and other appropriate components (oftenreferred to herein as modules).

Defibrillation lead 16 includes a lead body having a proximal end thatincludes a connector configured to connect to ICD 14 and a distal endthat includes one or more electrodes 18, 20, and 22. The lead body ofdefibrillation lead 16 may be formed from a non-conductive material,including silicone, polyurethane, fluoropolymers, mixtures thereof, andother appropriate materials, and shaped to form one or more lumenswithin which the one or more conductors extend. However, the techniquesare not limited to such constructions. Although defibrillation lead 16is illustrated as including three electrodes 18, 20 and 22,defibrillation lead 16 may include more or fewer electrodes.

Defibrillation lead 16 includes one or more elongated electricalconductors (not illustrated) that extend within the lead body from theconnector on the proximal end of defibrillation lead 16 to electrodes18, 20 and 22. In other words, each of the one or more elongatedelectrical conductors contained within the lead body of defibrillationlead 16 may engage with respective ones of electrodes 18, and 22. Whenthe connector at the proximal end of defibrillation lead 16 is connectedto ICD 14, the respective conductors may electrically couple tocircuitry, such as a therapy module or a sensing module, of ICD 14 viaconnections in connector assembly, including associated feedthroughs.The electrical conductors transmit therapy from a therapy module withinICD 14 to one or more of electrodes 18, 20 and 22 and transmit sensedelectrical signals from one or more of electrodes 18, 20 and 22 to thesensing module within ICD 14.

ICD 14 may sense electrical activity of heart 26 via one or more sensingvectors that include combinations of electrodes 20 and 22 and thehousing or can of ICD 14. For example, ICD 14 may obtain electricalsignals sensed using a sensing vector between electrodes 20 and 22,obtain electrical signals sensed using a sensing vector betweenelectrode 20 and the conductive housing or can of ICD 14, obtainelectrical signals sensed using a sensing vector between electrode 22and the conductive housing or can 25 of ICD 14, or a combinationthereof. In some instances, ICD 14 may sense cardiac electrical signalsusing a sensing vector that includes defibrillation electrode 18, suchas a sensing vector between defibrillation electrode 18 and one ofelectrodes 20 or 22, or a sensing vector between defibrillationelectrode 18 and the housing or can 25 of ICD 14.

ICD may analyze the sensed electrical signals to detect tachycardia,such as ventricular tachycardia or ventricular fibrillation, and inresponse to detecting tachycardia may generate and deliver an electricaltherapy to heart 26. For example, ICD 14 may deliver one or moredefibrillation shocks via a therapy vector that includes defibrillationelectrode 18 of defibrillation lead 16 and the housing or can 25.Defibrillation electrode 18 may, for example, be an elongated coilelectrode or other type of electrode. In some instances, ICD 14 maydeliver one or more pacing therapies prior to or after delivery of thedefibrillation shock, such as anti-tachycardia pacing (ATP) or postshock pacing. In these instances, ICD 14 may generate and deliver pacingpulses via therapy vectors that include one or both of electrodes 20 and22 and/or the housing or can 25. Electrodes 20 and 22 may comprise ringelectrodes, hemispherical electrodes, coil electrodes, helix electrodes,segmented electrodes, directional electrodes, or other types ofelectrodes, or combination thereof. Electrodes 20 and 22 may be the sametype of electrodes or different types of electrodes, although in theexample of FIG. 1 both electrodes 20 and 22 are illustrated as ringelectrodes.

Defibrillation lead 16 may also include an attachment feature 29 at ortoward the distal end of lead 16. The attachment feature 29 may be aloop, link, or other attachment feature. For example, attachment feature29 may be a loop formed by a suture. As another example, attachmentfeature 29 may be a loop, link, ring of metal, coated metal or apolymer. The attachment feature 29 may be formed into any of a number ofshapes with uniform or varying thickness and varying dimensions.Attachment feature 29 may be integral to the lead or may be added by theuser prior to implantation. Attachment feature 29 may be useful to aidin implantation of lead 16 and/or for securing lead 16 to a desiredimplant location. In some instances, defibrillation lead 16 may includea fixation mechanism in addition to or instead of the attachmentfeature. Although defibrillation lead 16 is illustrated with anattachment feature 29, in other examples lead 16 may not include anattachment feature 29.

Lead 16 may also include a connector at the proximal end of lead 16,such as a DF4 connector, bifurcated connector (e.g., DF-1/IS-1connector), or other type of connector. The connector at the proximalend of lead 16 may include a terminal pin that couples to a port withinthe connector assembly of ICD 14. In some instances, lead 16 may includean attachment feature at the proximal end of lead 16 that may be coupledto an implant tool to aid in implantation of lead 16. The attachmentfeature at the proximal end of the lead may separate from the connectorand may be either integral to the lead or added by the user prior toimplantation.

Defibrillation lead 16 may also include a suture sleeve or otherfixation mechanism (not shown) located proximal to electrode 22 that isconfigured to fixate lead 16 near the xiphoid process or lower sternumlocation. The fixation mechanism (e.g., suture sleeve or othermechanism) may be integral to the lead or may be added by the user priorto implantation.

The example illustrated in FIG. 1 is exemplary in nature and should notbe considered limiting of the techniques described in this disclosure.For instance, extravascular cardiac defibrillation system 10 may includemore than one lead. In one example, extravascular cardiac defibrillationsystem 10 may include a pacing lead in addition to defibrillation lead16.

In the example illustrated in FIG. 1 , defibrillation lead 16 isimplanted subcutaneously, e.g., between the skin and the ribs orsternum. In other instances, defibrillation lead 16 (and/or the optionalpacing lead) may be implanted at other extravascular locations. In oneexample, defibrillation lead 16 may be implanted at least partially in asubsternal location. In such a configuration, at least a portion ofdefibrillation lead 16 may be placed under or below the sternum in themediastinum and, more particularly, in the anterior mediastinum. Theanterior mediastinum is bounded laterally by pleurae, posteriorly bypericardium, and anteriorly by sternum 28. Defibrillation lead 16 may beat least partially implanted in other extra-pericardial locations, i.e.,locations in the region around, but not in direct contact with, theouter surface of heart 26. These other extra-pericardial locations mayinclude in the mediastinum but offset from sternum 28, in the superiormediastinum, in the middle mediastinum, in the posterior mediastinum, inthe sub-xiphoid or inferior xiphoid area, near the apex of the heart, orother location not in direct contact with heart 26 and not subcutaneous.In still further instances, the lead may be implanted at a pericardialor epicardial location outside of the heart 26.

FIG. 2 is an exemplary schematic diagram of electronic circuitry withina hermetically sealed housing of a subcutaneous device according to anembodiment of the present invention. As illustrated in FIG. 2 ,subcutaneous device 14 includes a low voltage battery 153 coupled to apower supply (not shown) that supplies power to the circuitry of thesubcutaneous device 14 and the pacing output capacitors to supply pacingenergy in a manner well known in the art. The low voltage battery 153may be formed of one or two conventional LiCF_(x), LiMnO₂ or LiI₂ cells,for example. The subcutaneous device 14 also includes a high voltagebattery 112 that may be formed of one or two conventional LiSVO orLiMnO₂ cells. Although two both low voltage battery and a high voltagebattery are shown in FIG. 2 , according to an embodiment of the presentinvention, the device 14 could utilize a single battery for both highand low voltage uses.

Further referring to FIG. 2 , subcutaneous device 14 functions arecontrolled by means of software, firmware and hardware thatcooperatively monitor the ECG signal, determine when acardioversion-defibrillation shock or pacing is necessary, and deliverprescribed cardioversion-defibrillation and pacing therapies. Thesubcutaneous device 14 may incorporate circuitry set forth in commonlyassigned U.S. Pat. No. 5,163,427 “Apparatus for Delivering Single andMultiple Cardioversion and Defibrillation Pulses” to Keimel and U.S.Pat. No. 5,188,105 “Apparatus and Method for Treating a Tachyarrhythmia”to Keimel for selectively delivering single phase, simultaneous biphasicand sequential biphasic cardioversion-defibrillation shocks typicallyemploying ICD IPG housing electrodes 28 coupled to the COMMON output 123of high voltage output circuit 140 and cardioversion-defibrillationelectrode 24 disposed posterially and subcutaneously and coupled to theHVI output 113 of the high voltage output circuit 140.

The cardioversion-defibrillation shock energy and capacitor chargevoltages can be intermediate to those supplied by ICDs having at leastone cardioversion-defibrillation electrode in contact with the heart andmost AEDs having cardioversion-defibrillation electrodes in contact withthe skin. The typical maximum voltage necessary for ICDs using mostbiphasic waveforms is approximately 750 Volts with an associated maximumenergy of approximately 40 Joules. The typical maximum voltage necessaryfor AEDs is approximately 2000-5000 Volts with an associated maximumenergy of approximately 200-360 Joules depending upon the model andwaveform used. The subcutaneous device 14 of the present invention usesmaximum voltages in the range of about 300 to approximately 1000 Voltsand is associated with energies of approximately 25 to 150 joules ormore. The total high voltage capacitance could range from about 50 toabout 300 microfarads. Such cardioversion-defibrillation shocks are onlydelivered when a malignant tachyarrhythmia, e.g., ventricularfibrillation is detected through processing of the far field cardiac ECGemploying the detection algorithms as described herein below.

In FIG. 2 , sense amp 190 in conjunction with pacer/device timingcircuit 178 processes the far field ECG sense signal that is developedacross a particular ECG sense vector defined by a selected pair of thesubcutaneous electrodes 18, 20, 22 and the can or housing 25 of thedevice 14, or, optionally, a virtual signal (i.e., a mathematicalcombination of two vectors) if selected. The selection of the sensingelectrode pair is made through the switch matrix/MUX 191 in a manner toprovide the most reliable sensing of the ECG signal of interest, whichwould be the R wave for patients who are believed to be at risk ofventricular fibrillation leading to sudden death. The far field ECGsignals are passed through the switch matrix/MUX 191 to the input of thesense amplifier 190 that, in conjunction with pacer/device timingcircuit 178, evaluates the sensed EGM. Bradycardia, or asystole, istypically determined by an escape interval timer within the pacer timingcircuit 178 and/or the control circuit 144. Pace Trigger signals areapplied to the pacing pulse generator 192 generating pacing stimulationwhen the interval between successive R-waves exceeds the escapeinterval. Bradycardia pacing is often temporarily provided to maintaincardiac output after delivery of a cardioversion-defibrillation shockthat may cause the heart to slowly beat as it recovers back to normalfunction. Sensing subcutaneous far field signals in the presence ofnoise may be aided by the use of appropriate denial and extensibleaccommodation periods as described in U.S. Pat. No. 6,236,882 “NoiseRejection for Monitoring ECGs” to Lee, et al and incorporated herein byreference in its' entirety.

Detection of a malignant tachyarrhythmia is determined in the Controlcircuit 144 as a function of the intervals between R-wave sense eventsignals that are output from the pacer/device timing 178 and senseamplifier circuit 190 to the timing and control circuit 144. It shouldbe noted that the present invention utilizes not only interval basedsignal analysis method but also supplemental sensors and morphologyprocessing method and apparatus as described herein below.

Supplemental sensors such as tissue color, tissue oxygenation,respiration, patient activity and the like may be used to contribute tothe decision to apply or withhold a defibrillation therapy as describedgenerally in U.S. Pat. No. 5,464,434 “Medical Interventional DeviceResponsive to Sudden Hemodynamic Change” to Alt and incorporated hereinby reference in its entirety. Sensor processing block 194 providessensor data to microprocessor 142 via data bus 146. Specifically,patient activity and/or posture may be determined by the apparatus andmethod as described in U.S. Pat. No. 5,593,431 “Medical ServiceEmploying Multiple DC Accelerometers for Patient Activity and PostureSensing and Method” to Sheldon and incorporated herein by reference inits entirety. Patient respiration may be determined by the apparatus andmethod as described in U.S. Pat. No. 4,567,892 “Implantable CardiacPacemaker” to Plicchi, et al and incorporated herein by reference in itsentirety. Patient tissue oxygenation or tissue color may be determinedby the sensor apparatus and method as described in U.S. Pat. No.5,176,137 to Erickson, et al and incorporated herein by reference in itsentirety. The oxygen sensor of the '137 patent may be located in thesubcutaneous device pocket or, alternatively, located on the lead 18 toenable the sensing of contacting or near-contacting tissue oxygenationor color.

Certain steps in the performance of the detection algorithm criteria arecooperatively performed in microcomputer 142, including microprocessor,RAM and ROM, associated circuitry, and stored detection criteria thatmay be programmed into RAM via a telemetry interface (not shown)conventional in the art. Data and commands are exchanged betweenmicrocomputer 142 and timing and control circuit 144, pacertiming/amplifier circuit 178, and high voltage output circuit 140 via abi-directional data/control bus 146. The pacer timing/amplifier circuit178 and the control circuit 144 are clocked at a slow clock rate. Themicrocomputer 142 is normally asleep, but is awakened and operated by afast clock by interrupts developed by each R-wave sense event, onreceipt of a downlink telemetry programming instruction or upon deliveryof cardiac pacing pulses to perform any necessary mathematicalcalculations, to perform tachycardia and fibrillation detectionprocedures, and to update the time intervals monitored and controlled bythe timers in pacer/device timing circuitry 178.

When a malignant tachycardia is detected, high voltage capacitors 156,158, 160, and 162 are charged to a pre-programmed voltage level by ahigh-voltage charging circuit 164. It is generally consideredinefficient to maintain a constant charge on the high voltage outputcapacitors 156, 158, 160, 162. Instead, charging is initiated whencontrol circuit 144 issues a high voltage charge command HVCHG deliveredon line 145 to high voltage charge circuit 164 and charging iscontrolled by means of bi-directional control/data bus 166 and afeedback signal VCAP from the HV output circuit 140. High voltage outputcapacitors 156, 158, 160 and 162 may be of film, aluminum electrolyticor wet tantalum construction.

The negative terminal of high voltage battery 112 is directly coupled tosystem ground. Switch circuit 114 is normally open so that the positiveterminal of high voltage battery 112 is disconnected from the positivepower input of the high voltage charge circuit 164. The high voltagecharge command HVCHG is also conducted via conductor 149 to the controlinput of switch circuit 114, and switch circuit 114 closes in responseto connect positive high voltage battery voltage EXT B+ to the positivepower input of high voltage charge circuit 164. Switch circuit 114 maybe, for example, a field effect transistor (FET) with itssource-to-drain path interrupting the EXT B+ conductor 118 and its gatereceiving the HVCHG signal on conductor 145. High voltage charge circuit164 is thereby rendered ready to begin charging the high voltage outputcapacitors 156, 158, 160, and 162 with charging current from highvoltage battery 112.

High voltage output capacitors 156, 158, 160, and 162 may be charged tovery high voltages, e.g., 300-1000V, to be discharged through the bodyand heart between the electrode pair of subcutaneouscardioversion-defibrillation electrodes 113 and 123. The details of thevoltage charging circuitry are also not deemed to be critical withregard to practicing the present invention; one high voltage chargingcircuit believed to be suitable for the purposes of the presentinvention is disclosed. High voltage capacitors 156, 158, 160 and 162may be charged, for example, by high voltage charge circuit 164 and ahigh frequency, high-voltage transformer 168 as described in detail incommonly assigned U.S. Pat. No. 4,548,209 “Energy Converter forImplantable Cardioverter” to Wielders, et al. Proper charging polaritiesare maintained by diodes 170, 172, 174 and 176 interconnecting theoutput windings of high-voltage transformer 168 and the capacitors 156,158, 160, and 162. As noted above, the state of capacitor charge ismonitored by circuitry within the high voltage output circuit 140 thatprovides a VCAP, feedback signal indicative of the voltage to the timingand control circuit 144. Timing and control circuit 144 terminates thehigh voltage charge command HVCHG when the VCAP signal matches theprogrammed capacitor output voltage, i.e., thecardioversion-defibrillation peak shock voltage Control circuit 144 thendevelops first and second control signals NPULSE 1 and NPULSE 2,respectively, that are applied to the high voltage output circuit 140for triggering the delivery of cardioverting or defibrillating shocks.In particular, the NPULSE 1 signal triggers discharge of the firstcapacitor bank, comprising capacitors 156 and 158. The NPULSE 2 signaltriggers discharge of the first capacitor bank and a second capacitorbank, comprising capacitors 160 and 162. It is possible to selectbetween a plurality of output pulse regimes simply by modifying thenumber and time order of assertion of the NPULSE 1 and NPULSE 2 signals.The NPULSE 1 signals and NPULSE 2 signals may be provided sequentially,simultaneously or individually. In this way, control circuitry 144serves to control operation of the high voltage output stage 140, whichdelivers high energy cardioversion-defibrillation shocks between thepair of the cardioversion-defibrillation electrodes 18 and 25 coupled tothe HV-1 and COMMON output as shown in FIG. 2 .

Thus, subcutaneous device 14 monitors the patient's status and initiatesthe delivery of a cardioversion-defibrillation shock through thecardioversion-defibrillation electrodes 18 and 25 in response todetection of a tachyarrhythmia requiring cardioversion-defibrillation.The high HVCHG signal causes the high voltage battery 112 to beconnected through the switch circuit 114 with the high voltage chargecircuit 164 and the charging of output capacitors 156, 158, 160, and 162to commence. Charging continues until the programmed charge voltage isreflected by the VCAP signal, at which point control and timing circuit144 sets the HVCHG signal low terminating charging and opening switchcircuit 114. The subcutaneous device 14 can be programmed to attempt todeliver cardioversion shocks to the heart in the manners described abovein timed synchrony with a detected R-wave or can be programmed orfabricated to deliver defibrillation shocks to the heart in the mannersdescribed above without attempting to synchronize the delivery to adetected R-wave. Episode data related to the detection of thetachyarrhythmia and delivery of the cardioversion-defibrillation shockcan be stored in RAM for uplink telemetry transmission to an externalprogrammer as is well known in the art to facilitate in diagnosis of thepatient's cardiac state. A patient receiving the device 14 on aprophylactic basis would be instructed to report each such episode tothe attending physician for further evaluation of the patient'scondition and assessment for the need for implantation of a moresophisticated ICD.

Subcutaneous device 14 desirably includes telemetry circuit (not shownin FIG. 2 ), so that it is capable of being programmed by means ofexternal programmer 20 via a 2-way telemetry link (not shown). Uplinktelemetry allows device status and diagnostic/event data to be sent toexternal programmer 20 for review by the patient's physician. Downlinktelemetry allows the external programmer via physician control to allowthe programming of device function and the optimization of the detectionand therapy for a specific patient. Programmers and telemetry systemssuitable for use in the practice of the present invention have been wellknown for many years. Known programmers typically communicate with animplanted device via a bi-directional radio-frequency telemetry link, sothat the programmer can transmit control commands and operationalparameter values to be received by the implanted device, so that theimplanted device can communicate diagnostic and operational data to theprogrammer. Programmers believed to be suitable for the purposes ofpracticing the present invention include the Models 9790 and CareLink®programmers, commercially available from Medtronic, Inc., Minneapolis,Minn.

Various telemetry systems for providing the necessary communicationschannels between an external programming unit and an implanted devicehave been developed and are well known in the art. Telemetry systemsbelieved to be suitable for the purposes of practicing the presentinvention are disclosed, for example, in the following U.S. Patents:U.S. Pat. No. 5,127,404 to Wybomy et al. entitled “Telemetry Format forImplanted Medical Device”; U.S. Pat. No. 4,374,382 to Markowitz entitled“Marker Channel Telemetry System for a Medical Device”; and U.S. Pat.No. 4,556,063 to Thompson et al. entitled “Telemetry System for aMedical Device”. The Wybomy et al. '404, Markowitz '382, and Thompson etal. '063 patents are commonly assigned to the assignee of the presentinvention, and are each hereby incorporated by reference herein in theirrespective entireties.

According to an embodiment of the present invention, in order toautomatically select the preferred ECG vector set, it is necessary tohave an index of merit upon which to rate the quality of the signal.“Quality” is defined as the signal's ability to provide accurate heartrate estimation and accurate morphological waveform separation betweenthe patient's usual sinus rhythm and the patient's ventriculartachyarrhythmia.

Appropriate indices may include R-wave amplitude, R-wave peak amplitudeto waveform amplitude between R-waves (i.e., signal to noise ratio), lowso slope content, relative high versus low frequency power, meanfrequency estimation, probability density function, or some combinationof these metrics.

Automatic vector selection might be done at implantation or periodically(daily, weekly, monthly) or both. At implant, automatic vector selectionmay be initiated as part of an automatic device turn-on procedure thatperforms such activities as measure lead impedances and batteryvoltages. The device turn-on procedure may be initiated by theimplanting physician (e.g., by pressing a programmer button) or,alternatively, may be initiated automatically upon automatic detectionof device/lead implantation. The turn-on procedure may also use theautomatic vector selection criteria to determine if ECG vector qualityis adequate for the current patient and for the device and leadposition, prior to suturing the subcutaneous device 14 device in placeand closing the incision. Such an ECG quality indicator would allow theimplanting physician to maneuver the device to a new location ororientation to improve the quality of the ECG signals as required. Thepreferred ECG vector or vectors may also be selected at implant as partof the device turn-on procedure. The preferred vectors might be thosevectors with the indices that maximize rate estimation and detectionaccuracy. There may also be an a priori set of vectors that arepreferred by the physician, and as long as those vectors exceed someminimum threshold, or are only slightly worse than some other moredesirable vectors, the a priori preferred vectors are chosen. Certainvectors may be considered nearly identical such that they are not testedunless the a priori selected vector index falls below some predeterminedthreshold.

Depending upon metric power consumption and power requirements of thedevice, the ECG signal quality metric may be measured on the range ofvectors (or alternatively, a subset) as often as desired. Data may begathered, for example, on a minute, hourly, daily, weekly or monthlybasis. More frequent measurements (e.g., every minute) may be averagedover time and used to select vectors based upon susceptibility ofvectors to occasional noise, motion noise, or EMI, for example.

Alternatively, the subcutaneous device 14 may have an indicator/sensorof patient activity (piezo-resistive, accelerometer, impedance, or thelike) and delay automatic vector measurement during periods of moderateor high patient activity to periods of minimal to no activity. Onerepresentative scenario may include testing/evaluating ECG vectors oncedaily or weekly while the patient has been determined to be asleep(using an internal clock (e.g., 2:00 am) or, alternatively, infer sleepby determining the patient's position (via a 2- or 3-axis accelerometer)and a lack of activity).

If infrequent automatic, periodic measurements are made, it may also bedesirable to measure noise (e.g., muscle, motion. EMI, etc.) in thesignal and postpone the vector selection measurement when the noise hassubsided.

Subcutaneous device 14 may optionally have an indicator of the patient'sposture (via a 2- or 3-axis accelerometer). This sensor may be used toensure that the differences in ECG quality are not simply a result ofchanging posture/position. The sensor may be used to gather data in anumber of postures so that ECG quality may be averaged over thesepostures or, alternatively, selected for a preferred posture.

In the preferred embodiment, vector quality metric calculations wouldoccur a number of times over approximately 1 minute, once per day, foreach vector. These values would be averaged for each vector over thecourse of one week. Averaging may consist of a moving average orrecursive average depending on time weighting and memory considerations.In this example, the preferred vector(s) would be selected once perweek.

FIG. 3 is a state diagram of detection of arrhythmias in a medicaldevice according to an embodiment of the present invention. Asillustrated in FIG. 3 , during normal operation, the device 14 is in anot concerned state 302, during which R-wave intervals are beingevaluated to identify periods of rapid rates and/or the presence ofasystole. Upon detection of short R-wave intervals simultaneously in twoseparate ECG sensing vectors, indicative of an event that, if confirmed,may require the delivery of therapy, the device 14 transitions from thenot concerned state 302 to a concerned state 304. In the concerned state304 the device 14 evaluates a predetermined window of ECG signals todetermine the likelihood that the signal is corrupted with noise and todiscriminate rhythms requiring shock therapy from those that do notrequire shock therapy, using a combination of R-wave intervals and ECGsignal morphology information.

If a rhythm requiring shock therapy continues to be detected while inthe concerned state 304, the device 14 transitions from the concernedstate 304 to an armed state 306. If a rhythm requiring shock therapy isno longer detected while the device is in the concerned state 304 andthe R-wave intervals are determined to no longer be short, the device 14returns to the not concerned state 302. However, if a rhythm requiringshock therapy is no longer detected while the device is in the concernedstate 304, but the R-wave intervals continue to be detected as beingshort, processing continues in the concerned state 304.

In the armed state 306, the device 14 charges the high voltage shockingcapacitors and continues to monitor R-wave intervals and ECG signalmorphology for spontaneous termination. If spontaneous termination ofthe rhythm requiring shock therapy occurs, the device 14 returns to thenot concerned state 302. If the rhythm requiring shock therapy is stilldetermined to be occurring once the charging of the capacitors iscompleted, the device 14 transitions from the armed state 306 to a shockstate 308. In the shock state 308, the device 14 delivers a shock andreturns to the armed state 306 to evaluate the success of the therapydelivered.

The transitioning between the not concerned state 302, the concernedstate 304, the armed state 306 and the shock state 308 may be performedas described in detail in U.S. Pat. No. 7,894,894 to Stadler et al.,incorporated herein by reference in it's entirety.

FIG. 4 is a flowchart of a method for detecting arrhythmias in asubcutaneous device according to an embodiment of the presentdisclosure. As illustrated in FIG. 4 , device 14 continuously evaluatesthe two channels ECG1 and ECG2 associated with two predeterminedelectrode vectors to determine when sensed events occur. For example,the electrode vectors for the two channels ECG1 and ECG2 may include afirst vector (ECG1) selected between electrode positioned on lead 16 andthe housing or can 25 of ICD 14, while the other electrode vector (ECG2) is a vertical electrode vector between electrode 20 and electrode 22positioned along the lead 16. However, the two sensing channels may inany combination of possible vectors, including those formed by theelectrodes shown in FIG. 2 , or other additional electrodes (not shown)that may be included along the lead or positioned along the housing ofICD 14.

According to an embodiment of the present application, for example, thedevice 14 determines whether to transition from the not concerned state302 to the concerned state 304 by determining a heart rate estimate inresponse to the sensing of R-waves, as described in U.S. Pat. No.7,894,894 to Stadler et al., incorporated herein by reference in it'sentirety.

Upon transition from the not concerned state to the concerned state,Block 305, a most recent window of ECG data from both channels ECG1 andECG2 are utilized, such as three seconds, for example, so thatprocessing is triggered in the concerned state 304 by a three-secondtimeout, rather than by the sensing of an R-wave, which is utilized whenin the not concerned state 302. It is understood that while theprocessing is described as being triggered over a three second period,other times periods for the processing time utilized when in theconcerned state 304 may be chosen, but should preferably be within arange of 0.5 to 10 seconds. As a result, although sensing of individualR-waves continues to occur in both channels ECG1 and ECG2 when in theconcerned state 304, and the buffer of 12 R-R intervals continues to beupdated, the opportunities for changing from the concerned state 304 toanother state and the estimates of heart rate only occur once thethree-second timer expires. Upon initial entry to the concerned state304, it is advantageous to process the most recent three-seconds of ECGdata, i.e., ECG data for the three seconds leading up to the transitionto the concerned state 304. This requires a continuous circularbuffering of the most recent three seconds of ECG data even while in thenot concerned state 302.

While in the concerned state 304, the present invention determines howsinusoidal and how noisy the signals are in order to determine thelikelihood that a ventricular fibrillation (VF) or fast ventriculartachycardia (VT) event is taking place, since the more sinusoidal andlow noise the signal is, the more likely a VT/VF event is taking place.As illustrated in FIG. 4 , once the device transitions from the notconcerned state 302 to the concerned state 304, Block 305, a buffer foreach of the two channels ECG 1 and ECG2 for storing classifications of3-second segments of data as “shockable” or “non-shockable” is cleared.Processing of signals of the two channels ECG1 and ECG2 while in theconcerned state 304 is then triggered by the three second time period,rather than by the sensing of an R-wave utilized during the notconcerned state 302.

Once the three second time interval has expired, YES in Block 341,morphology characteristics of the signal during the three second timeinterval for each channel are utilized to determine whether the signalsare likely corrupted by noise artifacts and to characterize themorphology of the signal as “shockable” or “not shockable”. For example,using the signals associated with the three second time interval, adetermination is made for each channel ECG1 and ECG 2 as to whether thechannel is likely corrupted by noise, Block 342, and a determination isthen made as to whether both channels ECG1 and ECG2 are corrupted bynoise, Block 344. The determination as to whether both channels arecorrupted by noise may be made using known noise detection methods, suchas the noise detection described in U.S. Pat. No. 7,894,894 to Stadleret al., incorporated herein by reference in it's entirety.

Once the determination as to whether the channels ECG1 and ECG2 arecorrupted by noise is made, Block 342, a determination is made as towhether both channels are determined to be noise corrupted, Block 344.If the signal associated with both channels ECG1 and ECG2 is determinedto likely be corrupted by noise, both channels are classified as beingnot shockable, Block 347, and therefore a buffer for each channel ECG1and ECG 2 containing the last three classifications of the channel isupdated accordingly. If both channels ECG1 and ECG2 are not determinedto be likely corrupted by noise, No in Block 344, the devicedistinguishes between either one of the channels being not corrupted bynoise or both channels being not corrupted by noise by determiningwhether noise was determined to be likely in only one of the twochannels ECG1 and ECG2. Block 346.

If noise was likely in only one of the two channels, a determination ismade whether the signal for the channel not corrupted by noise, i.e.,the clean channel, is more likely associated with a VT event or with aVF event by determining, for example, whether the signal for thatchannel includes R-R intervals that are regular and the channel can betherefore classified as being relatively stable, Block 348. If the R-Rintervals are determined not to be relatively stable, NO in Block 348,the signal for that channel is identified as likely being associatedwith VF, which is then verified by determining whether the signal is ina VF shock zone, Block 350, described below. If R-R intervals for thatchannel are determined to be stable, YES in Block 348, the signal isidentified as likely being associated with VT, which is then verified bydetermining whether the signal is in a VT shock zone, Block 352,described below.

If noise was not likely for both of the channels, No in Block 346, i.e.,both channels are determined to be clean channels, a determination ismade whether the signal for both channels is more likely associated witha VT event or with a VF event by determining whether the signal for bothchannels includes R-R intervals that are regular and can be thereforeclassified as being relatively stable, Block 356, The determination inBlock 356 of whether the R-R intervals are determined to be relativelystable may be made using the method described in U.S. Pat. No. 7,894,894to Stadler et al., incorporated herein by reference in it's entirety. Ifthe R-R intervals are determined not to be relatively stable, NO inBlock 356, the signal for both channels is identified as likely beingassociated with VF, which is then verified by determining whether thesignal for each channel is in a VF shock zone, Block 360, describedbelow. If R-R intervals for both channels are determined to be stable,YES in Block 356, the signal is identified as likely being associatedwith VT, which is then verified by determining, based on both channels,whether the signal is in a VT shock zone. Block 358.

FIG. 5 is a graphical representation of a VF shock zone according to anembodiment of the present invention. As illustrated in FIG. 5 , a VFshock zone 500 is defined for each channel ECG1 and ECG2 based on therelationship between the calculated low slope content and the spectralwidth associated with the channel. For example, the shock zone isdefined by a first boundary 502 associated with the low slope contentset for by the equation:

Low slope content=−0.0013×spectral width+0.415  Equation 1

and a second boundary 504 associated with the spectral width set forthby the equation:

spectral width=200  Equation 2

The low slope content metric is calculated as the ratio of the number ofdata points with low slope to the total number of samples in the3-second segment. For example, according to an embodiment of the presentinvention, the difference between successive ECG samples is determinedas an approximation of the first derivative (i.e, the slope) of the ECGsignal. In particular, the raw signal for each channel is applied to afirst order derivative filter to obtain a derivative signal for thethree-second segment. The derivative signal is then rectified, dividedinto four equal sub-segments, and the largest absolute slope isestimated for each of the four sub-segments.

A determination is made as to whether the largest absolute slopes areless than a portion of the overall largest absolute slope for the wholethree-second segment, such as one-fifth of the overall absolute slope,for example. If the largest absolute slope is less than the portion ofthe overall slope, then the slope value for that sub-segment is setequal to the overall largest absolute slope. If the largest absoluteslope is not less than the portion of the overall slope, then the slopevalue for that sub-segment is set equal to the determined largestabsolute slope for the sub-segment.

Once the slope value for each of the sub-segments has been determinedand updated by being set equal to the largest slope for the three secondsegment, if necessary, the average of the four slopes is calculated anddivided by a predetermined factor, such as 16 for example, to obtain alow slope threshold. The low slope content is then obtained bydetermining the number of sample points in the three-second segmenthaving an absolute slope less than or equal to the low slope threshold.

According to an embodiment of the present invention, if, during thedetermination of the low slope threshold, the low slope threshold is afraction, rather than a whole number, a correction is made to the lowslope content to add a corresponding fraction of the samples. Forexample, if the threshold is determined to be 4.5, then the low slopecontent is the number of sample points having an absolute slope lessthan or equal to 4 plus one half of the number of sample points withslope equal to 5.

The spectral width metric, which corresponds to an estimate of thespectral width of the signal for the three-second segment associatedwith each channel ECG1 and ECG2, is defined, for example, as thedifference between the mean frequency and the fundamental frequency ofthe signal. According to an embodiment of the present invention, thespectral width metric is calculated by determining the differencebetween the most recent estimate of the RR-cycle length and the meanspectral period of the signal for that channel. As is known in the art,the mean spectral period is the inverse of the mean spectral frequency.

As can be seen in FIG. 5 , since noise 506 tends to have a relativelyhigher spectral width, and normal sinus rhythm 508 tends to have arelatively higher low slope content relative to VF, both noise 506 andnormal sinus rhythm 508 would be located outside the VF shock zone 500.

A determination is made for each channel ECG1 and ECG2 as to whether thelow slope content for that channel is less than both the first boundary502 and the spectral width is less than the second boundary 504, i.e.,the low slope content is less than −0.0013×spectral width+0.415, and thespectral width is less than 200. For example, once the event isdetermined to be associated with VF, i.e., the intervals for bothchannels are determined to be irregular, No in Block 356, adetermination is made that channel ECG1 is in the VF shock zone, Yes inBlock 360, if, for channel ECG1, both the low slope content is less thanthe first boundary 502 and the spectral width is less than the secondboundary 504. The three second segment for that channel ECG1 is thendetermined to be shockable, Block 363 and the associated buffer for thatchannel is updated accordingly. If either the low slope content for thechannel is not less than the first boundary 502 or the spectral width isnot less than the second boundary, the channel ECG1 is determined not tobe in the VF shock zone, No in Block 360, the three second segment forthat channel ECG1 is then determined to be not shockable, Block 365, andthe associated buffer is updated accordingly.

Similarly, a determination is made that channel ECG2 is in the VF shockzone, Yes in Block 362, if, for channel ECG2, both the low slope contentis less than the first boundary 502 and the spectral width is less thanthe second boundary 504. The three second segment for that channel ECG2is then determined to be shockable, Block 369 and the associated bufferfor that channel is updated accordingly. If either the low slope contentfor the channel is not less than the first boundary 502 or the spectralwidth is not less than the second boundary, the channel ECG2 isdetermined not to be in the VF shock zone, No in Block 362, the threesecond segment for that channel ECG2 is then determined to be notshockable, Block 367, and the associated buffer is updated accordingly.

FIGS. 6A and 68 are graphical representations of the determination ofwhether an event is within a shock zone according to an embodiment ofthe present invention. During the determination of whether the event iswithin the VT shock zone, Block 358 of FIG. 4 , the low slope contentand the spectral width is determined for each channel ECG1 and ECG2, asdescribed above in reference to determining the VF shock zone. Adetermination is made as to which channel of the two signal channelsECG1 and ECG2 contains the minimum low slope content and which channelof the two signal channels ECG 1 and ECG2 contains the minimum spectralwidth. A first VT shock zone 520 is defined based on the relationshipbetween the low slope content associated with the channel determined tohave the minimum low slope content and the spectral width associatedwith the channel determined to have the minimum spectral width. Forexample, according to an embodiment of the present invention, the firstVT shock zone 520 is defined by a boundary 522 associated with theminimum low slope content and the minimum spectral width set forth bythe equation:

LSC=−0.004×SW+0.93  Equation 1

A second VT shock zone 524 is defined based on the relationship betweenthe low slope content associated with the channel determined to have theminimum low slope content and the normalized mean rectified amplitudeassociated with the channel determined to have the maximum normalizedmean rectified amplitude. In order to determine the normalized meanrectified amplitudes for the two channels ECG1 and ECG2 utilized duringthe VT shock zone test, the amplitude of each sample associated with thethree second window is determined, resulting in N sample amplitudes,from which a mean rectified amplitude is calculated as the ratio of thesum of the rectified sample amplitudes to the total number of sampleamplitudes N for the segment. If the sampling rate is 256 samples persecond, for example, the total number of sample amplitudes N for thethree-second segment would be N=768 samples.

According to an embodiment of the present invention, for example, thesecond VT shock zone 524 is defined by a second boundary 526 associatedwith the relationship between the minimum low slope count and themaximum normalized mean rectified amplitude set forth by the equation:

NMRA=68×LSC+8.16  Equation 2

If both the minimum low slope count is less than the first boundary 522,i.e., −0.004×minimum spectral width+0.93, and the maximum normalizedmean rectified amplitude is greater than the second boundary 526, i.e.,68×minimum low slope count+8.16, the event is determined to be in the VTshock zone, YES in Block 358, and both channels ECG1 and ECG2 aredetermined to be shockable, Block 357, and the associated buffers areupdated accordingly. If either the minimum low slope count is not lessthan the first boundary 522 or the maximum normalized mean rectifiedamplitude is not greater than the second boundary 526, the event isdetermined to be outside the VT shock zone, NO in Block 358, and bothchannels ECG1 and ECG2 are determined to be not shockable, Block 359.

As described, during both the VF shock zone test, Blocks 360 and 362,and the VT shock zone test, Block 358, the test results for each channelECG1 and ECG2 as being classified as shockable or not shockable arestored in a rolling buffer containing the most recent eight suchdesignations, for example, for each of the two channels ECG1 and ECG2that is utilized in the determination of Block 356, as described below.

If only one of the two channels ECG1 and ECG2 is determined to becorrupted by noise, Yes in Block 346, a determination is made whetherthe signal for the channel not corrupted by noise, i.e., the “cleanchannel”, is more likely associated with a VT event or with a VF eventby determining whether the signal for the clean channel includes R-Rintervals that are regular and can be therefore classified as beingrelatively stable, Block 348. If the R-R intervals are determined not tobe relatively stable, NO in Block 348, the signal for the clean channelis identified as likely being associated with VF, which is then verifiedby determining whether the signal for the clean channel is in a VF shockzone, Block 350, described below. If R-R intervals for the clean channelare determined to be stable, YES in Block 348, the signal is identifiedas likely being associated with VT, which is then verified bydetermining whether the signal for the clean channel is in a VT shockzone, Block 352.

According to an embodiment of the present invention, in order todetermine whether the signal for the clean channel includes R-Rintervals that are regular and the clean channel can be thereforeclassified as being either relatively stable, Yes in Block 348, orrelatively unstable, No in Block 348, the device discriminates VT eventsfrom VF events in Block 348 by determining whether the relative level ofvariation in the RR-intervals associated with the clean channel isregular. FIG. 7 is a flowchart of a method for discriminating cardiacevents according to an embodiment of the disclosure. For example, asillustrated in FIG. 7 , predetermined maximum and minimum intervals forthe clean channel are identified from the updated buffer of 12RR-intervals, Block 342 of FIG. 4 . According to an embodiment of thepresent invention, the largest RR-interval and the sixth largestRR-interval of the twelve RR-intervals are utilized as the maximuminterval and the minimum interval, respectively.

The difference between the maximum RR-interval and the minimumRR-interval of the 12 RR-intervals is calculated to generate an intervaldifference associated with the clean channel, 702. A determination isthen made as to whether the interval difference is greater than apredetermined stability threshold, Block 704, such as 110 milliseconds,for example.

If the interval difference is greater than the stability threshold, theevent is classified as an unstable event. Block 706, and therefore theclean channel is determined not to include regular intervals, No inBlock 348, and a determination is made as to whether the signalassociated with the clean channel is within a predetermined VF shockzone. Block 350 of FIG. 4 , described below. If the interval differenceis less than or equal to the stability threshold, No in Block 704, thedevice determines whether the minimum RR interval is greater than aminimum interval threshold, Block 710, such as 200 milliseconds, forexample.

If the minimum interval is less than or equal to the minimum intervalthreshold, No in Block 710, the event is classified as an unstableevent, Block 706, and therefore the clean channel is determined not toinclude regular intervals. No in Block 348, and a determination is madeas to whether the signal associated with the clean channel is within apredetermined VF shock zone, Block 350 of FIG. 4 , described below. Ifthe minimum interval is greater than the minimum interval threshold, Yesin Block 710, the device determines whether the maximum interval is lessthan or equal to a maximum interval threshold. Block 712, such as 333milliseconds for example. If the maximum interval is greater than themaximum interval threshold, the event is classified as an unstableevent, Block 706, and therefore the clean channel is determined not toinclude regular intervals. No in Block 348, and a determination is madeas to whether the signal associated with the clean channel is within apredetermined VF shock zone, Block 350 of FIG. 4 , described below. Ifthe maximum interval is less than or equal to the maximum intervalthreshold, the event is classified as a stable event, Block 714, andtherefore the dean channel is determined to include regular intervals.Yes in Block 348, and a determination is made as to whether the signalassociated with the clean channel is within a predetermined VT shockzone, Block 352 of FIG. 4 , described below.

Returning to FIG. 4 , the determination of whether the clean channel iswithin the VF shock zone, Block 350, is made based upon a low slopecontent metric and a spectral width metric, similar to the VF shock zonedetermination described above in reference to Blocks 360 and 362, bothof which are determined for the clean channel using the method describedabove. Once the low slope content metric and a spectral width metric aredetermined for the dean channel, the determination of whether the cleanchannel is in the VF shock zone is made using Equations 1 and 2, so thatif either the low slope content for the clean channel is not less thanthe first boundary 502 or the spectral width is not less than the secondboundary 504, the clean channel is determined not to be in the VF zone,No in Block 350 and both channels are classified as not shockable, Block351, and the associated buffers are updated accordingly.

If the low slope content for the clean channel is less than the firstboundary 502 and the spectral width is less than the second boundary504, the clean channel is determined to be in the VF zone, Yes in Block350. A determination is then made as to whether the channel determinedto be corrupted by noise, i.e., the “noisy channel”, is within the VFshock zone, Block 354. If either the low slope content for the noisychannel is not less than the first boundary 502 or the spectral width isnot less than the second boundary 504, the noisy channel is determinednot to be in the VF zone, No in Block 354, the clean channel isclassified as shockable and the noisy channel is classified as notshockable, Block 355, and the associated buffers are updatedaccordingly.

If the low slope content for the noisy channel is less than the firstboundary 502 and the spectral width is less than the second boundary504, the noisy channel is determined to be in the VF zone. Yes in Block354, both the clean channel and the noisy channel are classified asbeing shockable, Block 353, and the associated buffers are updatedaccordingly.

Similar to the VT shock zone determination described above in referenceto Block 358, during the determination as to whether the clean channelis within the VT shock zone in Block 352, the low slope content and thespectral width is determined for the clean channel as described above inreference to determining the VF shock zone. The first VT shock zone 520is defined based on the relationship between the low slope content andthe spectral width associated with the clean channel according toEquation 3, for example, and the second VT shock zone 524 is definedbased on the relationship between the low slope count and the normalizedmean rectified amplitude associated with the clean channel. Thenormalized mean rectified amplitudes for the clean channel is the sameas described above in reference to the noise detection tests of Block344. For example, according to an embodiment of the present invention,the second VT shock zone 524 is defined by a second boundary 526associated with the relationship between the low slope count and thenormalized mean rectified amplitude of the clean channel using Equation2.

If both the low slope count is less than the first boundary 522, i.e.,−0.004×spectral width of clean channel+0.93, and the normalized meanrectified amplitude is greater than the second boundary 526, i.e.,68×low slope count of clean channel+8.16, the clean channel isdetermined to be in the VT shock zone, Yes in Block 352, both channelsare classified as being shockable. Block 353, and the associated buffersare updated accordingly.

If either the low slope count is not less than the first boundary 522 orthe maximum normalized mean rectified amplitude is not greater than thesecond boundary 526, the clean channel is determined to be outside theVT shock zone, No in Block 352, both channels are classified as beingnot shockable, Block 351, and the associated buffers are updatedaccordingly.

Once the classification of both of the channels ECG1 and ECG2 is madesubsequent to the determination of whether the clean channel or channelsis in the VT shock zone, Block 352 and 358, or the VF shock zone, Blocks350 and Blocks 360 and 362 in combination, a determination is made as towhether the device should transition from the concerned state 304 to thearmed state 306, Block 370. For example, according to an embodiment ofthe present invention, the transition from the concerned state 304 tothe armed state 306 is confirmed if a predetermined number, such as twoout of three for example, of three-second segments for both channelsECG1 and ECG2 have been classified as being shockable. If thepredetermined number of three-second segments in both channels ECG1 andECG2 have been classified as shockable, the device transitions from theconcerned state 304 to the armed state 306. Yes in Block 370. If thepredetermined number of three-second segments in both channels ECG1 andECG2 have not been classified as shockable, the device does nottransition from the concerned state 304 to the armed state 306, no inBlock 370, and a determination as to whether to transition back to thenot concerned state 302 is made. Block 372. The determination as towhether to transition from the concerned state 304 back to the notconcerned state 302 is made, for example, by determining whether a heartrate estimate is less than a heart rate threshold level in both of thetwo channels ECG1 and ECG2, using the method for determining a heartrate estimate as described in U.S. Pat. No. 7,894,894 to Stadler et al.,incorporated herein by reference in its entirety. If it is determinedthat the device should not transition to the not concerned state 302,i.e., either of the two heart rate estimates are greater than the heartrate threshold, the process is repeated using the signal generatedduring a next three-second window. Block 341.

When the device determines to transition from the concerned state 304 tothe armed state 306, Yes in Block 370, processing continues to betriggered by a three-second time out as is utilized during the concernedstate 304, described above. Prior to making the operating statetransition from the concerned state 304 to the armed state, the deviceperforms a state transition rhythm confirmation analysis, Block 373, toconfirm the decision to transition from the concerned state to the armedstate that was made based on the predetermined number of three-secondsegments for both channels ECG1 and ECG2 having been classified as beingshockable, Block 370.

FIG. 8 is a flowchart of a method for determining whether the device isto transition between operating states according to an embodiment of thepresent invention. For example, as illustrated in FIGS. 4 and 8 , duringthe state transition rhythm confirmation analysis, Block 373, the deviceanalyzes the rhythm associated with the current episode, Block 800,using the three-second windows for both of the sensing channels ECG1 andECG2 that were previously used in the initial determination of whetherto transition to the next operating state, Block 370, prior to the statetransition rhythm confirmation analysis. Block 373. During the rhythmanalysis, Block 800, the device analyzes the previously detected rhythmto determine whether the rhythm is a monomorphic ventricular tachycardia(MVT) or a polymorphic ventricular tachycardia/fibrillation (PVT).

For example, according to one embodiment, the device analyzes the mostrecent determined three-second windows that were used to identify thecardiac event as being shockable, Blocks 342-370 of FIG. 4 , and foreach three-second window associated with sensing channels ECG1 and ECG2,the device compares the morphology of the one of the R-waves in thewindow with the morphology of the other R-waves in the window. Accordingto one embodiment, for example, the first R-wave is selected, and thecomparison is made between each of the subsequent R-waves in the windowand the first R-wave. If a predetermined number of the beats in thewindow match the morphology of the selected beat, the device determinesthe rhythm to be monomorphic VT for that sensing window. According to anembodiment of the present disclosure, the device determines, for eachbeat within the window, whether the beat matches the selected beat by apredetermined percentage match. For example, the device determineswhether there is a 60 percent or greater match between each beat and theselected beat in the three-second sensing window, and determines therhythm for the window to be monomorphic VT if all of the subsequentbeats are a 60 percent or greater match with the selected beat.According to another embodiment, the device may determine the rhythm forthe window to be monomorphic VT if a substantial fraction of the otherbeats, such as 66 percent or 75 percent, for example, are a 60 percentor greater match with the selected beat. The process is repeated foreach of the three-second windows utilized previously to determinewhether to transition to the next operating state in Block 370 of FIG. 4. If the rhythm is determined to be a monomorphic VT for each of theprevious determined three-second windows, the device determines that therhythm is a monomorphic VT. Yes in Block 802.

On the other hand, if a predetermined number of the beats in the windowdo not match the morphology of the selected beat, the device determinesthe rhythm not to be monomorphic for that sensing window. If either ofthe three second windows for both of the sensing channels ECG1 and ECG2are not determined to be monomorphic, the rhythm is not determined to bea monomorphic VT, No in Block 802, and is therefore likely a polymorphicVT/VF. As a result, the rhythm confirmation analysis is aborted and thedevice transitions from the concerned state 304 to the armed state 306,Block 804, where charging of the capacitor or capacitors is initiated.The operation of the device while in the armed state 306 is described inU.S. Pat. No. 7,894,894 to Stadler et al., incorporated herein byreference in it's entirety.

When the three-second windows of both of the sensing channels ECG1 andECG2 used previously to determine whether to transition to the nextoperating state in Block 370 of FIG. 4 are determined to be monomorphicVT, Yes in Block 802, the device delays transitioning from the notconcerned state 304 to the concerned state, Block 806. During thisoperating state transition delay, Block 806, the device waits for thenext determination, from Bocks 342-370 of FIG. 4 , of whether thesensing channels ECG1 and ECG2 are shockable or not shockable to beperformed using one or more of the next three-second windows from thesensing channels ECG1 and ECG2 subsequent to the three-second windowsthat were used previously in the determination of whether to transitionfrom the concerned operating state 304 to the armed operating state 306,Block 370. Therefore, if two consecutive three-second windows were usedin the determination, for example, the delay would be six seconds, andif only one were utilized, the delay would be three-seconds.

Once identified as being monomorphic VT, cardiac rhythms typically tendto subsequently present in one of three ways. The monomorphic VT rhythmmay subsequently further deteriorate from being a monomorphic VT rhythmto becoming a polymorphic VT or VF rhythm, may continue presenting as amonomorphic VT rhythm, or may self-terminate shortly after presenting asa monomorphic VT rhythm. Therefore, according to an embodiment of thepresent disclosure, once the next three-second windows are determined,the device analyzes the newly determined three-second windows. Block808, by comparing, for each of the current three-second windows ECG1 andECG2, the morphology of the first R-wave, i.e., the first beat in eachnewly determined three-second window with the morphology of thesubsequent R-waves in the window, as described above in Block 800.

If a predetermined number of the subsequent beats in the window matchthe morphology of the first beat, the device determines the rhythm to bemonomorphic in that sensing window. If the rhythm is determined to be amonomorphic VT for each sensing window: ECG1 and ECG2, the devicedetermines that the rhythm continues to be a monomorphic VT, Yes inBlock 810, and therefore the rhythm confirmation analysis is aborted andthe device transitions from the concerned state 304 to the armed state306. Block 804, where charging of the capacitor or capacitors isinitiated.

If one or more of the subsequently determined three second windows forboth of the sensing channels ECG1 and ECG2 are not determined to bemonomorphic, and therefore the cardiac event is likely no longermonomorphic ventricular tachycardia, No in Block 810, the devicedetermines whether the rhythm has terminated. Block 812. According toone embodiment, in order to determine whether the rhythm has terminatedin Block 812, the device compares, for each subsequently determinedthree-second window, the absolute value of each R-wave in the window toa predetermined width threshold. According to one embodiment, the widththreshold may be set as approximately 109 milliseconds, for example.

If all of the beats within the sensing window are greater than or equalto the width threshold, the rhythm for that window is determined to beassociated with ventricular tachycardia, and therefore, to have notterminated, No in Block 812. If all of the beats within the sensingwindow are less than the width threshold, the rhythm for that window isdetermined to be associated with supraventricular tachycardia, andtherefore, to have terminated, Yes in Block 812, and the devicedetermines to whether to transition back to the not concerned state 302,Block 372, as described above.

According to another embodiment, in order to determine whether therhythm has terminated in Block 812, the device compares, for eachsubsequently determined three-second window, each R-wave within thewindow with a predetermined sinus rhythm R-wave template to determine adifference between the R-waves and the sinus rhythm R-wave template. Ifthe difference between any one or more of the R-waves within the windowis greater than a predetermined difference threshold, such as 39milliseconds, for example, the rhythm is determined to be a ventriculartachycardia, and therefore to have not terminated, No in Block 812. Ifthe difference between each of the R-waves within the window is lessthan or equal to the predetermined difference threshold, the rhythm isdetermined to be a supraventricular tachycardia, and therefore to haveterminated, Yes in Block 812.

When the rhythm is determined to no longer be a monomorphic VT and tohave not terminated, No in Block 812, the device transitions from theconcerned state 304 to the armed state 306, where charging of thecapacitor or capacitors is initiated. If the rhythm is determined to nolonger be a monomorphic VT and to have terminated, Yes in Block 812, thedevice determines to whether to transition back to the not concernedstate 302, Block 372, as described above, Block 814.

In this way, during the confirmation as to whether to transition fromthe concerned operating state 304 to the armed operating state 306,Block 373, the device delays charging of the capacitors for the periodof time during which one or more of the next three-second windows areutilized to determine whether the rhythm is a monomorphic VT during thesubsequent analysis of Blocks 800 and 808.

According to another embodiment, if the rhythm is determined to nolonger be a monomorphic VT and to have terminated, Yes in Block 812, thedevice may automatically adjust the delay period so that duringsubsequent monomorphic ventricular tachycardia determinations, the delayperiod is adjusted from it's initial value to another desired value. Forexample, according to one embodiment, for the initial monomorphicventricular tachycardia determination in Block 810, the delay may be setas six seconds, i.e., two three-second windows, and if monomorphicventricular tachycardia is determined to have terminated, YES in Block812, the device increases the delay from six seconds to nine seconds,i.e., from two to three three-second windows. In addition the delay maybe decreased. For example, if the delay is set at nine seconds, and thedevice determines that the rhythm continues to be monomorphicventricular tachycardia. YES in Block 810, or to have not terminated, Noin Block 812, the device may decrease the delay from nine seconds to sixseconds when subsequent determinations are made in Block 810.

According to another embodiment, If one or more of the subsequentlydetermined three second windows for both of the sensing channels ECG1and ECG2 are not determined to be monomorphic, and therefore the cardiacevent is likely no longer monomorphic ventricular tachycardia, No inBlock 810, the device does not make the determination as to whether therhythm has terminated, Block 812. Rather, when the rhythm terminationdetermination. Block 812, is omitted, and it is determined that thecardiac event is likely no longer monomorphic ventricular tachycardia,No in Block 810, the device determines whether to transition back to thenot concerned state 302, Block 372, as described above. Thedetermination as to whether the rhythm is no longer a shockable eventwill be made based on the analysis of the next three-second windows inBlocks 342-370.

FIG. 9 is a flowchart of a method for determining whether to transitionbetween operating states in a medical device according to an embodimentof the present invention. As described above, the device transitionsfrom the concerned operating state 306 to the armed operating state 306,Yes in Block 370 of FIG. 4 , when two out of three three-second segmentsfor both channels ECG1 and ECG2 have been classified as being shockable,and performs the state transition rhythm confirmation, Block 373, usingthe three-second windows for both of the sensing channels ECG1 and ECG2that were previously used in the initial determination of whether totransition to the next operating state, Block 370, prior to the statetransition rhythm confirmation analysis. Block 373.

As can be seen in FIG. 4 , how both channels ECG1 and ECG2 could havebeen determined to be shockable can vary. First, if noise was determinedto be occurring in one channel, Yes in Block 346, but the clean channelwas determined to have regular intervals, Yes in Block 348, and to be inthe VT shock zone, Yes in Block 352, both of the sensing channels ECG1and ECG2 are determined to be shockable. Block 353. Second, if noise wasdetermined to be occurring in one channel, Yes in Block 346, the cleanchannel was determined not to have regular intervals, No in Block 348,and both the clean and the noisy channel are determined to be in the VFshock zone, Yes in Blocks 350 and 354, both of the sensing channels ECG1and ECG2 are determined to be shockable, Block 353.

On the other hand, if noise was not determined to be occurring in eitherchannel, No in Block 346, but both channels are determined to haveregular intervals, Yes in Block 356, and both channels are determined tobe in the VT shock zone, Yes in Block 358, both of the sensing channelsECG1 and ECG2 are determined to be shockable, Block 359. Finally, ifnoise was not determined to be occurring in either channel, No in Block346, but both channels are not determined to have regular intervals, Noin Block 356, and both channels are determined to be in the VF shockzone, Yes in Blocks 360 and 362, both of the sensing channels ECG1 andECG2 are determined to be shockable. Therefore, according to anembodiment of the present disclosure, the device may determine how thethree-second windows were determined to be shockable, and based on thisdetermination, decide whether or not to perform the state transitionrhythm confirmation, Block 373, and if the confirmation is to beperformed, whether one or both of the sensing channels ECG1 and ECG2 areto be used in performing the confirmation.

For example, as illustrated in FIGS. 4, 8 and 9 , according to anembodiment of the present disclosure, during the state transition rhythmconfirmation, Block 373, the device determines the condition of thesensing channels, ECG1 and ECG2, Block 816, utilized during the initialdetermination, Blocks 342-370, as to whether the sensing channels ECG1and ECG2 are shockable or not shockable. For example, the devicedetermines whether noise was determined in one of the sensing channels,ECG1 or ECG2, Block 818. If noise was determined to be occurring in oneof the sensing channels. Yes in Block 818, the device determines whetherthe signal for the clean channel included R-R intervals that wereregular and the channel was be therefore classified as being relativelystable, Block 820. If the R-R intervals were determined to not berelatively regular or stable for the dean channel, No in Block 820, thedevice determines that the state transition rhythm confirmation, Block373, is not to be performed, Block 822, and that the transition to thearmed state 306 should be initiated without delay, Block 824. If the R-Rintervals were determined to be relatively regular or stable. Yes inBlock 820, the device determines that the state transition rhythmconfirmation, Block 373, is to be performed and that the clean channelonly is to be utilized, Block 826, in the confirmation, Block 828, asdescribed below.

If noise was not determined to be occurring one of the sensing channels,i.e., both sensing channels were dean, Yes in Block 818, the devicedetermines whether the signal for both channels included R-R intervalsthat were regular and the channel was be therefore classified as beingrelatively stable, Block 830. If the R-R intervals were determined tonot be relatively regular or stable for both channels, No in Block 830,the device determines that the state transition rhythm confirmation,Block 373, is not to be performed, Block 822, and that the transition tothe armed state 306 should be initiated without delay, Block 824. If theR-R intervals were determined to be relatively regular or stable forboth channels, Yes in Block 830, the device determines that the statetransition rhythm confirmation, Block 373, is to be performed and thatboth channels are to be utilized, Block 832, in the confirmation, Block828, as described above.

If only the single clean channel is determined to be utilized in theconfirmation, Block 828, the device analyzes the rhythm associated withthe current episode, Block 800, using the three-second windows for theonly the dean sensing channel ECG1 or ECG2 used during the initialdetermination of whether to transition to the next operating state.Block 370, prior to the state transition rhythm confirmation analysis.Block 373. During the rhythm analysis, Block 800, the device analyzesthe previously detected rhythm in the clean sensing channel ECG1 or ECG2to determine whether the rhythm is a monomorphic ventricular tachycardia(MVT) or a polymorphic ventricular tachycardia/fibrillation (PVT).

For example, according to one embodiment, the device analyses the mostrecent determined three second windows, and for each clean three-secondwindow ECG1 or ECG2, compares the morphology of the first R-wave, i.e.,the first beat, in the window with the morphology of the subsequentR-waves in the window. If a predetermined number of the subsequent beatsin the window match the morphology of the first beat, the devicedetermines the rhythm to be monomorphic for that sensing window. If therhythm is determined to be a monomorphic VT for the clean sensingwindow, ECG1 or ECG2, the device determines that the rhythm is amonomorphic VT, Yes in Block 802.

On the other hand, if the three second windows for the dean sensingchannel ECG1 or ECG2 is not determined to be monomorphic, NO in Block802, the rhythm is not determined to be a monomorphic VT, No in Block802, and is therefore likely a polymorphic VT/VF. Therefore, rhythmconfirmation analysis is aborted and the device transitions from theconcerned state 304 to the armed state 306, Block 804, where charging ofthe capacitor or capacitors is initiated. The operation of the devicewhile in the armed state 306 is described in U.S. Pat. No. 7,894,894 toStadler et al., incorporated herein by reference in its entirety.

When the three second windows of the clean sensing channel ECG1 or ECG2is determined to be monomorphic VT, Yes in Block 802, the device delaystransitioning from the not concerned state 304 to the concerned state,Block 806. During this operating state transition delay. Block 806, thedevice waits for the next determination, from Bocks 342-370 of FIG. 4 ,of whether the sensing channels ECG1 and ECG2 are shockable or notshockable to be performed using the next three-second windows from thesensing channels ECG1 and ECG2 subsequent to the three-second windowsthat were already used previously in the determination of whether totransition from the concerned operating state 304 to the armed operatingstate 306, Block 370.

As described above, the device analyzes the newly determinedthree-second windows, Block 808, by comparing, for the currentthree-second window of the clean channel ECG1 or ECG2, the morphology ofthe first R-wave, i.e., the first beat in each newly determinedthree-second window for the clean sensing channel with the morphology ofthe subsequent R-waves in the window.

If a predetermined number of the subsequent beats in the window matchthe morphology of the first beat, the device determines the rhythm to bemonomorphic in that sensing window. If the rhythm is determined to be amonomorphic VT for each sensing window, ECG1 and ECG2, the devicedetermines that the rhythm is continues to be a monomorphic VT, Yes inBlock 810, and therefore the rhythm confirmation analysis is aborted andthe device transitions from the concerned state 304 to the armed state306, Block 804, where charging of the capacitor or capacitors isinitiated.

If the subsequently determined three second window for the clean sensingchannel ECG1 or ECG2 is not determined to be monomorphic. NO in Block810, the device determines whether the rhythm has terminated, Block 812,as described below. If the rhythm is determined to no longer be amonomorphic VT and to have not terminated, No in Block 812, the devicetransitions from the concerned state 304 to the armed state 306, wherecharging of the capacitor or capacitors is initiated. If the rhythm isdetermined to no longer be a monomorphic VT and to have terminated, Yesin Block 812, the device determines to whether to transition back to thenot concerned state 302, Block 372, as described above.

FIG. 10 is a flowchart of a method for discriminating a cardiac eventaccording to an embodiment of the present disclosure. According to anembodiment of the present disclosure, the device may use one or morerhythm discrimination thresholds to further discriminate the rhythmduring the rhythm analysis in one or both of Blocks 800 and 808 as beingeither monomorphic, polymorphic or normal sinus rhythm. For example, asillustrated in FIG. 10 , once the rhythm is classified as beingshockable in Blocks 342-370 of FIG. 4 , Block 900, the device comparesthe R-waves in the previously determined three-second windows used indetermining to transition from the concerned operating state 304 to thearmed operating state 306 to generate a template match score for each ofthe R-waves in the window. A determination is made for each sensingvector as to whether the match scores for the interval of the sensingvector exceed a predetermined match score threshold.

For example, the device compares the morphology of the one of theR-waves in the window with the morphology of the other R-waves in thewindow. According to one embodiment, for example, the first R-wave isselected as the template, and the comparison is made between each of thesubsequent R-waves in the window and the first R-wave. If apredetermined number of the beats in the window match the morphology ofthe selected beat, the device determines the rhythm to be monomorphicfor that sensing window.

According to an embodiment of the present disclosure, the devicedetermines, for each beat within the window, whether the beat matchesthe selected beat by a predetermined percentage match. For example,according to one embodiment, the device determines whether there is a 60percent or greater match between each beat and the selected beat in thethree-second sensing window, and determines the rhythm for the window tobe monomorphic VT if all of the subsequent beats are a 60 percent orgreater match with the selected beat. According to another embodiment,the device may determine the rhythm for the window to be monomorphic VTif a substantial fraction of the other beats, such as 66 percent or 75percent, for example, are a 60 percent or greater match with theselected beat. The process is repeated for each of the three-secondwindows utilized previously to determine whether to transition to thenext operating state in Block 370 of FIG. 4 .

If the predetermined number of the match scores are not determined to bewithin the match score range for both sensing vectors if two are beingutilized, or for the one sensing vector if only one sensing vector isbeing utilized, and so forth, the VT morphology match is determined notto be satisfied, No in Block 902, and the rhythm is therefore determinedto likely be associated with a treatable rhythm, such as polymorphic VT,ventricular fibrillation or ventricular flutter, Block 904. As a result,the rhythm confirmation analysis is aborted and the device transitionsfrom the concerned state 304 to the armed state 306, Block 906, wherecharging of the capacitor or capacitors is initiated, as describedabove.

If all of the subsequent beats match the selected beat by apredetermined percentage match threshold and therefore the rhythm isdetermined to be monomorphic for each of the previous determinedthree-second windows, the device determines that the rhythm is amonomorphic rhythm, Yes in Block 902. However, because a monomorphicrhythm could be either sinus tachycardia/supraventricular tachycardia,monomorphic ventricular tachycardia, or ventricular flutter, in order tofurther distinguish the a monomorphic rhythm, the device determines, foreach window, whether a predetermined number of R-wave widths associatedwith the beats in each of the three-second windows is within apredetermined range reflective of a given cardiac rhythm, Block 908. Forexample, according to an embodiment of the present disclosure, thedevice compares, for each three-second window, the absolute value ofeach R-wave in the window to a predetermined R-wave width threshold.According to one embodiment, the width threshold may be set asapproximately 109 milliseconds, for example, and the device determineswhether all of the beats within the window are less than the widththreshold.

If the predetermined number of beats within the sensing window are lessthe width threshold, the R-wave width threshold for that window isdetermined to be satisfied. On the other hand, if the predeterminednumber of beats within the sensing window are not less than the widththreshold, the R-wave width threshold for that window is determined notto be satisfied.

The process is repeated for all of the three-second windows beingutilized in the rhythm confirmation analysis, and if the R-wave widththreshold is determined to be satisfied for each three-second window.Yes in Block 908, the monomorphic rhythm is therefore determined tolikely be associated with a normal rhythm not requiring shock therapy,such as normal sinus rhythm, sinus tachycardia, or supraventriculartachycardia, Block 910. As a result, the rhythm confirmation analysis iscompleted and the device determines to whether to transition back to thenot concerned state 302, Block 372 of FIG. 4 : as described above, Block912.

If the R-wave width threshold is determined to not be satisfied for oneor more of the three-second windows, and therefore the R-wave widththreshold is determined not to be satisfied, No in Block 908, themonomorphic rhythm determined to be associated with either monomorphicventricular tachycardia or ventricular flutter. Since a rhythmassociated with ventricular flutter is typically more sinusoidal than arhythm associated with monomorphic ventricular tachycardia, in order tofurther distinguish between the rhythm as being either monomorphicventricular tachycardia or ventricular flutter, the device determineswhether a monomorphic signal metric for indicating the cardiac event asbeing a sinusoidal event is satisfied, Block 914. In order to determinewhether a monomorphic signal metric is satisfied, the device determines,for each three-second window utilized, whether the signal for the windowsatisfies the monomorphic signal metric.

According to one embodiment, the determination of whether themonomorphic signal metric is satisfied is made using a determined lowslope content metric in combination with a determined normalized meanrectified amplitude for each relevant three-second window. The low slopecontent metric may be calculated as the ratio of the number of datapoints with low slope to the total number of samples in the 3-secondsegment. For example, according to an embodiment of the presentinvention, the difference between successive ECG samples is determinedas an approximation of the first derivative (i.e, the slope) of the ECGsignal. In particular, the raw signal for each channel is applied to afirst order derivative filter to obtain a derivative signal for thethree-second segment. The derivative signal is then rectified, dividedinto four equal sub-segments, and the largest absolute slope isestimated for each of the four sub-segments.

A determination is made as to whether the largest absolute slopes areless than a portion of the overall largest absolute slope for the wholethree-second segment, such as one-fifth of the overall absolute slope,for example. If the largest absolute slope is less than the portion ofthe overall slope, then the slope value for that sub-segment is setequal to the overall largest absolute slope. If the largest absoluteslope is not less than the portion of the overall slope, then the slopevalue for that sub-segment is set equal to the determined largestabsolute slope for the sub-segment.

Once the slope value for each of the sub-segments has been determinedand updated by being set equal to the largest slope for the three secondsegment, if necessary, the average of the four slopes is calculated anddivided by a predetermined factor, such as 16 for example, to obtain alow slope threshold. The low slope content is then obtained bydetermining the number of sample points in the three-second segmenthaving an absolute slope less than or equal to the low slope threshold.

According to an embodiment of the present invention, if, during thedetermination of the low slope threshold, the low slope threshold is afraction, rather than a whole number, a correction is made to the lowslope content to add a corresponding fraction of the samples. Forexample, if the threshold is determined to be 4.5, then the low slopecontent is the number of sample points having an absolute slope lessthan or equal to 4 plus one half of the number of sample points withslope equal to 5.

In order to determine the normalized mean rectified amplitudes for thetwo channels ECG1 and ECG2 utilized during the determination of themorphology signal metric, the amplitude of each R-wave associated withthe three second window is determined, resulting in N sample amplitudes,from which a mean rectified amplitude is calculated as the ratio of thesum of the rectified sample amplitudes to the total number of sampleamplitudes N for the segment. If the sampling rate is 256 samples persecond, for example, the total number of sample amplitudes N for thethree-second segment would be N=768 samples.

The determined low slope content for each utilized sensing window iscompared to a low slope content threshold, such as 0.2, for example, andthe determined normalized mean rectified amplitude is compared to anamplitude threshold, such as 60 for example. If both the low slopecontent is less than the low slope content threshold and the normalizedmean rectified amplitude is greater than the amplitude threshold, themorphology metric is determined to be satisfied for that sensing window.

If one or more of the rhythms for the three-second windows aredetermined to not satisfy the monomorphic signal metric, the cardiacevent is determined not to satisfy the monomorphic signal metric, No inBlock 914, and the cardiac event is determined to be a non-terminatingmonomorphic VT rhythm, Block 916. If all of the rhythms for thethree-second windows are determined to satisfy the monomorphic signalmetric, the cardiac event is determined to satisfy the monomorphicsignal metric, Yes in Block 914, the cardiac event is determined to beventricular flutter, Block 904, and as a result, the rhythm confirmationanalysis is aborted and the device transitions from the concerned state304 to the armed state 306, Block 906, where charging of the capacitoror capacitors is initiated, as described above.

FIG. 11 is a flowchart of a method for determining whether the device isto transition between operating states according to an embodiment of thepresent invention. According to an embodiment of the present disclosure,the additional discrimination of FIG. 10 may be utilized during theinitial rhythm analysis Block 800 of the state transition rhythmconfirmation Block 373. For example, as illustrated in FIG. 11 , oncethe rhythm is classified as being shockable in Blocks 342-370 of FIG. 4, Block 918, the device compares the R-waves in the previouslydetermined three-second windows used in determining to transition fromthe concerned operating state 304 to the armed operating state 306 togenerate a template match score for each of the R-waves in the window. Adetermination is made for each sensing vector as to whether the matchscores for the interval of the sensing vector exceed a predeterminedmatch score threshold.

For example, the device compares the morphology of the one of theR-waves in the window with the morphology of the other R-waves in thewindow. According to one embodiment, for example, the first R-wave isselected as the template, and the comparison is made between each of thesubsequent R-waves in the window and the first R-wave. If apredetermined number of the beats in the window match the morphology ofthe selected beat, the device determines the rhythm to be monomorphicfor that sensing window.

According to an embodiment of the present disclosure, the devicedetermines, for each beat within the window, whether the beat matchesthe selected beat by a predetermined percentage match. For example,according to one embodiment, the device determines whether there is a 60percent or greater match between each beat and the selected beat in thethree-second sensing window, and determines the rhythm for the window tobe monomorphic VT if all of the subsequent beats are a 60 percent orgreater match with the selected beat. According to another embodiment,the device may determine the rhythm for the window to be monomorphic VTif a substantial fraction of the other beats, such as 66 percent or 75percent, for example, are a 60 percent or greater match with theselected beat. The process is repeated for each of the three-secondwindows utilized previously to determine whether to transition to thenext operating state in Block 370 of FIG. 4 .

If the predetermined number of the match scores are not determined to bewithin the match score range for both sensing vectors if two are beingutilized, or for the one sensing vector if only one sensing vector isbeing utilized, and so forth, the VT morphology match is determined notto be satisfied, No in Block 920, and the rhythm is therefore determinedto likely be associated with a treatable rhythm, such as polymorphic VT,ventricular fibrillation or ventricular flutter, Block 904. As a result,the rhythm confirmation analysis is aborted and the device transitionsfrom the concerned state 304 to the armed state 306, Block 906, wherecharging of the capacitor or capacitors is initiated, as describedabove.

If all of the subsequent beats match the selected beat by apredetermined percentage match threshold and therefore the rhythm isdetermined to be monomorphic for each of the previous determinedthree-second windows, the device determines that the rhythm is amonomorphic rhythm, Yes in Block 920. However, because a monomorphicrhythm could be either sinus tachycardia/supraventricular tachycardia,monomorphic ventricular tachycardia, or ventricular flutter, in order tofurther distinguish the a monomorphic rhythm, the device determines, foreach window, whether a predetermined number of R-wave widths associatedwith the beats in each of the three-second windows is within apredetermined range reflective of a given cardiac rhythm, Block 926. Forexample, according to an embodiment of the present disclosure, thedevice compares, for each three-second window, the absolute value ofeach R-wave in the window to a predetermined R-wave width threshold.According to one embodiment, the width threshold may be set asapproximately 109 milliseconds, for example, and the device determineswhether all of the beats within the window are less than the widththreshold.

If the predetermined number of beats within the sensing window are lessthe width threshold, the R-wave width threshold for that window isdetermined to be satisfied. On the other hand, if the predeterminednumber of beats within the sensing window are not less than the widththreshold, the R-wave width threshold for that window is determined notto be satisfied.

The process is repeated for all of the three-second windows beingutilized in the rhythm confirmation analysis, and if the R-wave widththreshold is determined to be satisfied for each three-second window,Yes in Block 926, the monomorphic rhythm is therefore determined tolikely be associated with a normal rhythm not requiring shock therapy,such as normal sinus rhythm, sinus tachycardia, or supraventriculartachycardia, Block 928. As a result, the rhythm confirmation analysis iscompleted and the device determines to whether to transition back to thenot concerned state 302, Block 372 of FIG. 4 , as described above, Block930.

If the R-wave width threshold is determined to not be satisfied for oneor more of the three-second windows, and therefore the R-wave widththreshold is determined not to be satisfied, No in Block 926, themonomorphic rhythm is determined to be associated with eithermonomorphic ventricular tachycardia or ventricular flutter. Since arhythm associated with ventricular flutter is typically more sinusoidalthan a rhythm associated with monomorphic ventricular tachycardia, inorder to further distinguish between the rhythm as being eithermonomorphic ventricular tachycardia or ventricular flutter, the devicedetermines whether a monomorphic signal metric for indicating thecardiac event as being a sinusoidal event is satisfied. Block 932. Inorder to determine whether a monomorphic signal metric is satisfied, thedevice determines, for each three-second window utilized, whether thesignal for the window satisfies the monomorphic signal metric, asdescribed above.

If all of the rhythms for the three-second windows are determined tosatisfy the monomorphic signal metric, the cardiac event is determinedto satisfy the monomorphic signal metric, Yes in Block 932, the cardiacevent is determined to be ventricular flutter, which is a treatablerhythm, Block 922, and as a result, the rhythm confirmation analysis isaborted and the device transitions from the concerned state 304 to thearmed state 306, Block 924, where charging of the capacitor orcapacitors is initiated, as described above. If one or more of therhythms for the three-second windows are determined to not satisfy themonomorphic signal metric, the cardiac event is determined not tosatisfy the monomorphic signal metric, No in Block 932, and the cardiacevent is determined to be a non-terminating monomorphic VT rhythm. Block934.

Once the event is determined to be a monomorphic ventricular tachycardiarhythm, Block 934, the device delays transitioning from the notconcerned state 304 to the concerned state, Block 936, as describedabove. During this operating state transition delay. Block 936, thedevice waits for the next determination, from Bocks 342-370 of FIG. 4 ,of whether the sensing channels ECG1 and ECG2 are shockable or notshockable to be performed using the next three-second windows from thesensing channels ECG1 and ECG2 subsequent to the three-second windowsthat were used previously in the determination of whether to transitionfrom the concerned operating state 304 to the armed operating state 306,Block 370.

Once the next determination of whether the sensing channels ECG1 andECG2 are shockable or not shockable is completed, the device analyzesthe newly determined three-second windows, Block 938, by comparing, foreach of the current three-second windows ECG1 and ECG2, the morphologyof the first R-wave, i.e., the first beat in each newly determinedthree-second window with the morphology of the subsequent R-waves in thewindow, as described above in Block 800.

If a predetermined number of the subsequent beats in the window matchthe morphology of the first beat, the device determines the rhythm to bemonomorphic in that sensing window. If the rhythm is determined to be amonomorphic VT for each sensing window, ECG1 and ECG2, the devicedetermines that the rhythm continues to be a monomorphic VT, Yes inBlock 940, and therefore the rhythm confirmation analysis is aborted andthe device transitions from the concerned state 304 to the armed state306, Block 924, where charging of the capacitor or capacitors isinitiated.

If one or more of the subsequently determined three second windows forboth of the sensing channels ECG1 and ECG2 are not determined to bemonomorphic, NO in Block 940, the device may determine whether therhythm has terminated, Block 942. According to one embodiment, in orderto determine whether the rhythm has terminated in Block 942, the devicecompares, for each subsequently determined three-second window, theabsolute value of each R-wave in the window to a predetermined widththreshold. According to one embodiment, the width threshold may be setas approximately 109 milliseconds, for example.

If all of the beats within the sensing window are greater than or equalto the width threshold, the rhythm for that window is determined to beassociated with ventricular tachycardia, and therefore, to have notterminated, No in Block 942. If all of the beats within the sensingwindow are less than the width threshold, the rhythm for that window isdetermined to be associated with supraventricular tachycardia, andtherefore, to have terminated, Yes in Block 942, and the devicedetermines to whether to transition back to the not concerned state 302,Block 372, as described above. Block 930.

FIG. 12 is flowchart of a method for determining whether the device isto transition between operating states according to an embodiment of thepresent invention. According to an embodiment, as illustrated in FIGS. 4and 12 , during the state transition rhythm confirmation analysis, Block373, the device analyzes the rhythm associated with the current episode,Block 850, using the three-second windows for both of the sensingchannels ECG1 and ECG2 that were previously used in the initialdetermination of whether to transition to the next operating state,Block 370, prior to the state transition rhythm confirmation analysis,Block 373. During the rhythm analysis, Block 850, the device analyzesthe previously detected rhythm to determine whether the rhythm is amonomorphic ventricular tachycardia (MVT) or a polymorphic ventriculartachycardia/fibrillation (PVT).

For example, according to one embodiment, the device analyzes the mostrecent determined three-second windows that were used to identify thecardiac event as being shockable, Blocks 342-370 of FIG. 4 , and foreach three-second window associated with sensing channels ECG1 and ECG2,the device compares the morphology of the one of the R-waves in thewindow with the morphology of the other R-waves in the window. Accordingto one embodiment, for example, the first R-wave is selected, and thecomparison is made between each of the subsequent R-waves in the windowand the first R-wave. If a predetermined number of the beats in thewindow match the morphology of the selected beat, the device determinesthe rhythm to be monomorphic VT for that sensing window.

According to an embodiment of the present disclosure, the devicedetermines, for each beat within the window, whether the beat matchesthe selected beat by a predetermined percentage match. For example, thedevice determines whether there is a 60 percent or greater match betweeneach beat and the selected beat in the three-second sensing window, anddetermines the rhythm for the window to be monomorphic VT if all of thesubsequent beats are a 60 percent or greater match with the selectedbeat. According to another embodiment, the device may determine therhythm for the window to be monomorphic VT if a substantial fraction ofthe other beats, such as 66 percent or 75 percent, for example, are a 60percent or greater match with the selected beat. The process is repeatedfor each of the three-second windows utilized previously to determinewhether to transition to the next operating state in Block 370 of FIG. 4. If the rhythm is determined to be a monomorphic VT for each of theprevious determined three-second windows, the device determines that therhythm is a monomorphic VT, Yes in Block 852.

On the other hand, if a predetermined number of the beats in the windowdo not match the morphology of the selected beat, the device determinesthe rhythm not to be monomorphic for that sensing window. If either ofthe three second windows for both of the sensing channels ECG1 and ECG2are not determined to be monomorphic, the rhythm is not determined to bea monomorphic VT, No in Block 852, and is therefore likely a polymorphicVT/VF. As a result, the rhythm confirmation analysis is aborted and thedevice transitions from the concerned state 304 to the armed state 306,Block 854, where charging of the capacitor or capacitors is initiated.The operation of the device while in the armed state 306 is described inU.S. Pat. No. 7,894,894 to Stadler et al., incorporated herein byreference in it's entirety.

When the three-second windows of both of the sensing channels ECG1 andECG2 used previously to determine whether to transition to the nextoperating state in Block 370 of FIG. 4 are determined to be monomorphicVT. Yes in Block 852, the device delays transitioning from the notconcerned state 304 to the concerned state. Block 856 for three seconds.During this operating state transition delay, Block 856, the devicewaits for the next determination, from Bocks 342-370 of FIG. 4 , ofwhether the sensing channels ECG1 and ECG2 are shockable or notshockable to be performed using the next two simultaneous three-secondwindows from the sensing channels ECG1 and ECG2 subsequent to thethree-second windows that were used previously in the determination ofwhether to transition from the concerned operating state 304 to thearmed operating state 306, Block 370.

The device analyzes the newly determined three-second window, Block 858,by comparing a selected R-wave in the newly simultaneously determinedthree-second windows ECG1 and ECG 2 with the morphology of the otherR-waves in the window, as described above, to determine, for each of thetwo simultaneously sensed windows, whether the three-second window isassociated with monomorphic ventricular tachycardia, Block 860.

If a predetermined number of the beats in the window do match themorphology of the selected beat, the rhythm for the three-second windowcontaining the beats is determined to be monomorphic VT. On the otherhand, if a predetermined number of the beats in the window do not matchthe morphology of the selected beat, the rhythm for the three-secondwindow containing the beats is determined not to be monomorphic VT. Ifone or both of the simultaneous three-second sensing windows ECG1 andECG2 are determined not to be monomorphic VT, the device determines therhythm to no longer be monomorphic VT, No in Block 860. A determinationis then made as to whether the rhythm is a ventricular fibrillation,Block 864.

According to an embodiment, the device may determine whether the rhythmis ventricular fibrillation in Block 864 using the programmedtachycardia threshold of the device, such as whether the rate associatedwith the rhythm is greater than 240 beats per minute, for example.According to another embodiment, the device may determine whether therhythm is ventricular fibrillation in Block 864 by determining whetherthe rhythm has increased by a predetermined rate, such as 30 beats perminute, for example, from the prior rate of the established monomorphicventricular tachycardia. If the rhythm determined is to be ventricularfibrillation, Yes in Block 864, the device transitions from theconcerned state 304 to the armed state 306, Block 804, where charging ofthe capacitor or capacitors is initiated. If the rhythm is notdetermined to be ventricular fibrillation, No in Block 864, the devicedetermines to whether to transition back to the not concerned state 302,Block 372, as described above, Block 866.

If both of the simultaneous three-second sensing windows ECG1 and ECG2are determined to be monomorphic VT, the device determines the rhythm tocontinue to be monomorphic VT for those three-second windows, Yes inBlock 860. A determination is then made as to whether the total delayperiod has terminated by determining whether a timer has expired, Block862. For example, if the operating state transition delay Block 373 isto be performed for the next two simultaneously determined three-secondwindows, the total delay would be six seconds. Therefore, if six secondshave not expired since initiation of the operating state transitiondelay, No in Block 862, meaning that the shockable or not shockabledetermination, Blocks 342-370 of FIG. 4 , has only been determined forthe first two simultaneous sensings in the two sensing channels ECG 1and ECG 2, the device waits for the shockable or not shockabledetermination, Blocks 342-370 of FIG. 4 , to be completed for thesubsequent two simultaneous sensings in the two sensing channels ECG1and ECG 2, so that the delay process, Blocks 858-866, is then repeatedfor the next determined three-second windows.

If the rhythm is no longer monomorphic ventricular tachycardia for thesubsequent simultaneously determined three-second windows associatedwith the two sensing channels ECG 1 and ECG 2, No in Block 860, thedetermination as to whether the rhythm is ventricular fibrillation,Block 864, is repeated for the subsequent simultaneously determinedthree-second windows. If the subsequent rhythm is determined to beventricular fibrillation, Yes in Block 864, the device transitions fromthe concerned state 304 to the armed state 306. Block 804, wherecharging of the capacitor or capacitors is initiated. If the subsequentrhythm is not determined to be ventricular fibrillation, No in Block864, the device determines to whether to transition back to the notconcerned state 302, Block 372, as described above, Block 866.

If six seconds have expired since initiation of the operating statetransition delay, Yes in Block 862, meaning that the shockable or notshockable determination, Blocks 342-370 of FIG. 4 , has been determinedfor two consecutive simultaneously sensed windows corresponding to thetwo sensing channels ECG 1 and ECG 2, with none of the subsequentlysensed three second windows determined not to be monomorphic, indicatingthe rhythm continues to be monomorphic for the entire delay period, thedevice determines that the rhythm continues to be a monomorphic VT, andtherefore the rhythm confirmation analysis is aborted and the devicetransitions from the concerned state 304 to the armed state 306, Block854, where charging of the capacitor or capacitors is initiated.

FIG. 13 is flowchart of a method for determining whether the device isto transition between operating states according to an embodiment of thepresent invention. FIG. 13 is similar to FIG. 8 , with the exceptionthat during the determination as to whether the rhythm is monomorphicventricular tachycardia in Block 802, if the rhythm is determinedmonomorphic, Yes in Block 802, the device determines whether the rate ofmonomorphic ventricular tachycardia is greater than a predetermined ratethreshold, Block 803. According to one embodiment, the predeterminedrate threshold of Block 803 may be set to a rate between 240 and 300beats per minute for example.

If the rate of monomorphic ventricular tachycardia is greater than apredetermined rate threshold, Yes in Block 803, the device transitionsfrom the concerned state 304 to the armed state 306, Block 804, wherecharging of the capacitor or capacitors is initiated. If the rate ofmonomorphic ventricular tachycardia is not greater than a predeterminedrate threshold, No in Block 803, the device delays transitioning fromthe not concerned state 304 to the concerned state, Block 806, asdescribed above.

Thus, a method and apparatus for discriminating a cardiac event havebeen presented in the foregoing description with reference to specificembodiments. It is appreciated that various modifications to thereferenced embodiments may be made without departing from the scope ofthe disclosure as set forth in the following claims.

1-20. (canceled) 21: A device comprising: at least one output capacitor;and circuitry configured to: obtain a cardiac signal; perform a firstanalysis of a first segment of the cardiac signal; detect a shockableventricular cardiac event based on at least the first analysis of thefirst segment of the cardiac signal; perform a second analysis of thefirst segment of the cardiac signal, the second analysis being differentthan the first analysis; detect that the shockable ventricular cardiacevent is monomorphic ventricular tachycardia (MVT) based on the secondanalysis; and delay initiation of charging of the output capacitor inresponse to detecting that the shockable ventricular cardiac event isMVT. 22: The device of claim 21, wherein the circuitry is configured todetect that the shockable ventricular cardiac event is not MVT based onthe second analysis and initiate charging of the output capacitor inresponse to detecting that the shockable ventricular cardiac event isnot MVT; and the device further comprising control circuitry configuredto discharge the output capacitor to deliver shock therapy. 23: Thedevice of claim 21, wherein to perform the second analysis, thecircuitry is configured to: identify a plurality of R-waves within thefirst segment; and compare a morphology of a selected R-wave of theplurality of R-waves with a morphology of at least a portion ofremaining R-waves of the plurality of R-waves. 24: The device of claim23, wherein to perform the second analysis, the circuitry is configuredto: based on comparing the morphology of the selected R-wave of theplurality of R-waves with the morphology of at least the portion of theremaining R-waves of the plurality of R-waves, determine whether theshockable ventricular cardiac event is monomorphic ventriculartachycardia (MVT) or polymorphic ventricular tachycardia (PVT). 25: Thedevice of claim 24, wherein the circuitry is further configured to: inresponse to detecting that the shockable ventricular cardiac event isPVT, initiate charging of the output capacitor. 26: The device of claim23, wherein to perform the second analysis, the circuitry is furtherconfigured to: determine that a threshold number of the remainingR-waves of the plurality of R-waves have morphologies that match themorphology of the selected R-wave; and detect that the shockableventricular cardiac event is MVT in response to the threshold number ofthe remaining R-waves of the plurality of R-waves having morphologiesthat match the morphology of the selected R-wave. 27: The device ofclaim 21, wherein the circuitry is configured to: while delayingcharging of the output capacitor, performing the first analysis on atleast one of a second segment of the cardiac signal and a third segmentof a second cardiac signal, wherein the second segment and the thirdsegment correspond with portions of the cardiac signal and the secondcardiac signal that are simultaneously sensed and further wherein thesecond segment and the third segment are sensed after the first segment;detect, while delaying charging of the output capacitor, continuation ofthe shockable ventricular cardiac event based on the first analysis ofthe at least one of the second segment and the third segment; perform,while delaying charging of the output capacitor, the second analysis ofthe at least one of the second segment and the third segment; continue,while delaying charging of the output capacitor, to detect that theshockable ventricular cardiac event is MVT based on the second analysisof the at least one of the second segment and the third segment;initiate charging of the output capacitor in response to continuing todetect that the shockable ventricular cardiac event is MVT; anddischarge the output capacitor to deliver shock therapy. 28: The deviceof claim 21, wherein the circuitry is configured to: continue, whiledelaying charging of the output capacitor, to detect that the shockableventricular cardiac event is MVT for a threshold period of time; andinitiate charging of the output capacitor in response to continuing todetect that the shockable ventricular cardiac event is MVT for thethreshold period of time; and wherein the device further comprisescontrol circuitry configured to discharge the output capacitor todeliver shock therapy. 29: The device of claim 28, wherein the circuitryis configured to decrease the threshold period of time for whichcharging of the output capacitor is delayed for subsequently detectedMVT in response to the continued detection of the MVT. 30: The device ofclaim 21, wherein the circuitry is configured to: detect, while delayingcharging of the output capacitor, termination of the MVT; and continueto monitor for a subsequent shockable ventricular cardiac event withoutinitiating charging of the output capacitor for the shockableventricular cardiac event in response to detecting termination of theMVT. 31: The device of claim 30, wherein the circuitry is configured toincrease a period of time for which charging of a output capacitor isdelayed for subsequently detected MVT in response to detectingtermination of the MVT. 32: The device of claim 21, further comprising:a plurality of electrodes configured to sense the cardiac signal. 33:The device of claim 21, wherein the device comprises an implantabledevice. 34: A method comprising: obtaining, via a plurality ofelectrodes, a cardiac signal; performing, by circuitry, a first analysisof a first segment of the cardiac signal; detecting, by the circuitry, ashockable ventricular cardiac event based on at least the first analysisof the first segment of the cardiac signal; performing, by thecircuitry, a second analysis of the first cardiac signal, the secondanalysis being different than the first analysis; detecting, by thecircuitry, that the shockable ventricular cardiac event is monomorphicventricular tachycardia (MVT) based on the second analysis, anddelaying, by the circuitry, initiation of charging of a output capacitorin response to detecting that the shockable ventricular cardiac event isMVT. 35: The method of claim 34, further comprising: detecting, by thecircuitry for a second segment of a second cardiac signal, that theshockable ventricular cardiac event is not MVT based on the secondanalysis; and initiating, by the circuitry, charging of the outputcapacitor in response to detecting that the shockable ventricularcardiac event is not MVT; and discharging the output capacitor todeliver shock therapy. 36: The method of claim 34, wherein performingthe second analysis comprises: identifying a plurality of R-waves withinthe first segment; and comparing a morphology of a selected R-wave ofthe plurality of R-waves with a morphology of at least a portion ofremaining R-waves of the plurality of R-waves. 37: The method of claim36, wherein performing the second analysis comprises: based on comparingthe morphology of the selected R-wave of the plurality of R-waves withthe morphology of at least the portion of the remaining R-waves of theplurality of R-waves, determining whether the shockable ventricularcardiac event is monomorphic ventricular tachycardia (MVT) orpolymorphic ventricular tachycardia (PVT). 38: The method of claim 37,further comprising: in response to detecting that the shockableventricular cardiac event is PVT, initiating charging of the outputcapacitor. 39: A non-transitory, computer-readable storage mediumstoring instructions that when executed by processing circuitry in amedical device, cause the medical device to perform a process fordetermining a cardiac event and controlling shock therapy delivery viathe medical device, the instructions causing the processing circuitryto: obtain a cardiac signal; perform a first analysis of a segment ofthe cardiac signal; detect a shockable ventricular cardiac event basedon at least the first analysis of the segment of the cardiac signal;perform a second analysis of the first cardiac signal, the secondanalysis being different than the first analysis; detect that theshockable ventricular cardiac event is monomorphic ventriculartachycardia (MVT) based on the second analysis; and delay initiation ofcharging of a output capacitor in response to detecting that theshockable ventricular cardiac event is MVT. 40: The non-transitory,computer-readable storage medium of claim 39, wherein to perform thesecond analysis, the instructions cause the processing circuitry:identify a plurality of R-waves within the segment; and compare amorphology of a selected R-wave of the plurality of R-waves with amorphology of at least a portion of remaining R-waves of the pluralityof R-waves; and based on comparing the morphology of the selected R-waveof the plurality of R-waves with the morphology of at least the portionof the remaining R-waves of the plurality of R-waves, determine whetherthe shockable ventricular cardiac event is monomorphic ventriculartachycardia (MVT) or polymorphic ventricular tachycardia (PVT).